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임산부 철분+엽산

Prenatal Iron + Folate

📑 PubMed 5편 ♀️ 여성

📚 관련 논문 (20편)

1.
Inadequate iron stores in early term neonates.
Journal of perinatology : official journal of the California Perinatal Association 2018 PMID:29880794

1. J Perinatol. 2018 Aug;38(8):1017-1021. doi: 10.1038/s41372-018-0140-9. Epub 2018 Jun 8. Inadequate iron stores in early term neonates. Hua Y(1), Kaciroti N(2), Jiang Y(1), Li X(1), Xu G(1), Richards B(2), Li M(3), Lozoff B(4)(5). Author information: (1)Peking University First Hospital, Beiji

2.
Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates.
The Journal of nutrition 2015 PMID:26063068

2. J Nutr. 2015 Aug;145(8):1916-23. doi: 10.3945/jn.114.208678. Epub 2015 Jun 10. Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates. Zhao

3.
Factors associated with compliance of prenatal iron folate supplementation among women in Mecha district, Western Amhara: a cross-sectional study.
The Pan African medical journal 2015 PMID:26090001

3. Pan Afr Med J. 2015 Jan 15;20:43. doi: 10.11604/pamj.2015.20.43.4894. eCollection 2015. Factors associated with compliance of prenatal iron folate supplementation among women in Mecha district, Western Amhara: a cross-sectional study. Taye B(1), Abeje G(1), Mekonen A(1). Author information:

4.
Anemia among Pregnant Women Attending Ante Natal Care Clinic in Adare General Hospital, Southern Ethiopia: Prevalence and Associated Factors.
Health services insights 2021 PMID:34376992

4. Health Serv Insights. 2021 Jul 29;14:11786329211036303. doi: 10.1177/11786329211036303. eCollection 2021. Anemia among Pregnant Women Attending Ante Natal Care Clinic in Adare General Hospital, Southern Ethiopia: Prevalence and Associated Factors. Kare AP(1), Gujo AB(1). Author information:

5.
Determinants of anemia in postpartum HIV-negative women in Dar es Salaam, Tanzania.
European journal of clinical nutrition 2013 PMID:23612515

5. Eur J Clin Nutr. 2013 Jul;67(7):708-17. doi: 10.1038/ejcn.2013.71. Epub 2013 Apr 24. Determinants of anemia in postpartum HIV-negative women in Dar es Salaam, Tanzania. Petraro P(1), Duggan C, Urassa W, Msamanga G, Makubi A, Spiegelman D, Fawzi WW. Author information: (1)Department of Nutrit

6.
The effects of antenatal interventions on gestational weight gain in low and middle-income countries: a systematic review.
BMJ global health 2026 PMID:41927311

1. BMJ Glob Health. 2026 Apr 2;11(4):e019344. doi: 10.1136/bmjgh-2025-019344. The effects of antenatal interventions on gestational weight gain in low and middle-income countries: a systematic review. Aggrey PA(#)(1), Nguyen CH(#)(1), Asghari-Kamrani A(#)(1)(2), Fawzi WW(3)(4)(5), Wang D(6). Author information: (1)Department of Global and Community Health, George Mason University College of Public Health, Fairfax, Virginia, USA. (2)Department of Family Science, University of Maryland School of Public Health, College Park, Maryland, USA. (3)Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. (4)Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. (5)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. (6)Department of Global and Community Health, George Mason University College of Public Health, Fairfax, Virginia, USA dwang25@gmu.edu. (#)Contributed equally BACKGROUND: Gestational weight gain (GWG) during pregnancy is a critical factor that affects maternal and child health outcomes. The considerable burden of inadequate GWG and the rising tide of excessive GWG are overlooked challenges in low and middle-income countries (LMICs). METHODS: This systematic review assessed the impact of antenatal interventions on GWG in LMICs. Randomised controlled trials (RCTs) on antenatal interventions on GWG in LMICs were included. These interventions included educational, behavioural, nutritional supplementation and pharmacological therapies. A systematic literature search was conducted using PubMed, Embase, Web of Science, CINAHL and the Cochrane Library from the start of each database through September 2025. RESULTS: Out of the 33 642 unique articles identified, 70 articles were included in our systematic review, with 59 individual RCTs and 11 cluster RCTs. Nutritional interventions (31 studies) included food and micronutrient supplementations. Micronutrient supplementation such as multiple micronutrient supplementations was found to reduce the risk of severely inadequate or inadequate GWG among pregnant women compared to iron only or iron and folic acid supplementation (Grading of Recommendations Assessment, Development and Evaluation [GRADE]: moderate certainty). Food supplementation showed mixed results, although most trials demonstrated higher mean GWG among undernourished pregnant women and a greater likelihood of achieving Institute of Medicine-recommended ranges (GRADE: moderate certainty). Behavioural (counselling/education) interventions (20 studies) were associated with significant reductions in excessive GWG among pregnant women with overweight or obesity and improved adequacy of GWG (GRADE: moderate certainty). Physical activity (seven studies) was found to reduce the risk of excessive GWG (GRADE: moderate certainty). Combined dietary and physical activity interventions (six studies) were found to reduce the risk of excessive GWG among pregnant women (GRADE: low certainty). CONCLUSIONS: Well-structured antenatal interventions, initiated before 20 weeks of gestation and continuing beyond this period, tailored to local cultural contexts and available resources, can effectively help pregnant women in LMICs in achieving optimal GWG. PROSPERO REGISTRATION NUMBER: CRD42022366354. © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. DOI: 10.1136/bmjgh-2025-019344 PMCID: PMC13052686 PMID: 41927311 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: None declared.

7.
Effect on birthweight of an antenatal multiple micronutrient supplementation programme compared with iron-folic acid supplementation: a cluster-randomised, controlled trial in 85 698 Ethiopian women.
The Lancet. Global health 2026 PMID:41871585

2. Lancet Glob Health. 2026 May;14(5):e772-e780. doi: 10.1016/S2214-109X(26)00050-1. Epub 2026 Mar 20. Effect on birthweight of an antenatal multiple micronutrient supplementation programme compared with iron-folic acid supplementation: a cluster-randomised, controlled trial in 85 698 Ethiopian women. Tessema M(1), Defar A(2), Tessema B(3), Daba AK(3), Tollera G(3), Tesfa A(3), Opondo C(4), Persson LÅ(5), Schellenberg J(5), Marchant T(5). Author information: (1)Ethiopian Public Health Institute, Addis Ababa, Ethiopia. Electronic address: dr.masresha.tessema@gmail.com. (2)Ethiopian Public Health Institute, Addis Ababa, Ethiopia; Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. (3)Ethiopian Public Health Institute, Addis Ababa, Ethiopia. (4)Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK. (5)Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK. BACKGROUND: Prenatal multiple micronutrient supplementation (MMS) including iron, folic acid, and other essential micronutrients, has shown potential to improve birth outcomes in controlled studies. We did an effectiveness study in Ethiopia to determine the effect on mean birthweight of MMS provided as part of routine antenatal care, relative to iron-folic acid supplementation (IFA). METHODS: A pragmatic, two-arm, facility-based, cluster-randomised controlled trial was conducted across 42 districts in five regions of Ethiopia to determine the effect on birthweight of MMS relative to IFA. Districts were randomly assigned to either retain IFA as part of routine antenatal care or switch to MMS. Randomisation was stratified by region and done using a random number generator within statistical software. All live singleton births at participating health facilities were eligible for inclusion and birthweights were recorded. Additionally, data were collected on maternal receipt and utilisation of MMS or IFA. The primary outcome was birthweight, analysed in the intention-to-treat population. This completed trial is registered at ClinicalTrials.gov, NCT05708183. FINDINGS: Between Jan 1, 2023, and Dec 31, 2024, birthweights were recorded for 47 325 babies in the 21 IFA districts and 36 473 babies in the 21 MMS districts. Mean age of mothers was 26·2 years (SD 5·3) and median gestational age of babies at birth was 38 weeks (IQR 38-39). The effect of MMS on birthweight was a mean increase of 38 g (95% CI 20-55) in the MMS arm relative to the IFA arm after adjustment for time, geographical region stratification factor, gestational age, sex of baby, and parity. Among women who reported taking at least 90 tablets of their assigned supplement, the increase in mean birthweight in the MMS arm relative to the IFA arm was 58 g (38-79). Stillbirth risk was 7·5 per 1000 births in the IFA arm and 6·9 per 1000 births in the MMS arm. INTERPRETATION: The findings of this trial are consistent with those from efficacy trials in other settings, indicating that the transition from IFA to MMS as part of routine antenatal care in Ethiopia could lead to a small but clear improvement in birthweight, although adherence to supplements and programme sustainability require careful attention. FUNDING: Children's Investment Fund Foundation. Copyright © 2026 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved. DOI: 10.1016/S2214-109X(26)00050-1 PMID: 41871585 [Indexed for MEDLINE] Conflict of interest statement: Declaration of interests We declare no competing interests.

8.
The effect of prenatal balanced energy and protein supplementation on small vulnerable newborn types in low- and middle-income countries: A systematic review and meta-analysis of individual participant data.
PLoS medicine 2026 PMID:41701774

3. PLoS Med. 2026 Feb 17;23(2):e1004716. doi: 10.1371/journal.pmed.1004716. eCollection 2026 Feb. The effect of prenatal balanced energy and protein supplementation on small vulnerable newborn types in low- and middle-income countries: A systematic review and meta-analysis of individual participant data. Wang D(1), Partap U(2), Liu E(3)(4), Costa JC(2), Cliffer IR(2), Wang M(5)(6)(7), Nookala SK(8), Subramoney V(9), Briggs B(10), Ahmed I(11), Argaw A(12), Ariff S(11), Bhandari N(13), Chowdhury R(13), Dailey-Chwalibóg T(12)(14), Hanley-Cook GT(15), Huybregts L(12)(16), Jehan F(17), Krebs NF(18), Lachat C(12), Manandhar DS(19), McClure EM(20), Moore SE(21)(22), Muhammad A(23), Nisar MI(17), Prentice AM(22), Roberfroid D(24)(25), Saville NM(26), Shafiq Y(27)(28)(29), Shrestha BP(19), Sonko B(22), Soofi S(11), Taneja S(13), Toe LC(12)(30), Fawzi WW(2)(5)(31). Author information: (1)Department of Global and Community Health, College of Public Health, George Mason University, Fairfax, Virginia, United States of America. (2)Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America. (3)Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts, United States of America. (4)Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America. (5)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America. (6)Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America. (7)Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America. (8)Cytel Inc., India, on behalf of the Gates Foundation, Seattle, Washington, United States of America. (9)DVPL Tech, Dubai, United Arab Emirates. (10)Certara USA, Inc., on behalf of the Gates Foundation, Seattle, Washington, United States of America. (11)Aga Khan University, Karachi, Pakistan. (12)Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium. (13)Society for Applied Studies, New Delhi, India. (14)Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté), Bobo-Dioulasso, Burkina Faso. (15)Food and Nutrition Division, Food and Agriculture Organization of the United Nations (FAO), Rome, Italy. (16)Nutrition, Diets, and Health Unit, International Food Policy Research Institute, Washington, District of Columbia, United States of America. (17)Department of Pediatrics and Child Health, The Aga Khan University, Karachi, Pakistan. (18)University of Colorado School of Medicine, Aurora, Colorado, United States of America. (19)Mother and Infant Research Activities (MIRA), Kathmandu, Nepal. (20)RTI International, Durham, North Carolina, United States of America. (21)Department of Women & Children's Health, King's College London, London, United Kingdom. (22)MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia. (23)VITAL Pakistan Trust, Karachi, Pakistan. (24)Faculty of Medicine, University of Namur, Namur, Belgium. (25)Belgian Health Care Knowledge Centre, Brussels, Belgium. (26)Institute for Global Health, University College London, London, United Kingdom. (27)Center of Excellence for Trauma and Emergencies and Community Health Sciences, The Aga Khan University, Karachi, Pakistan. (28)Global Advancement of Infants and Mothers (AIM), Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America. (29)Harvard Humanitarian Initiative, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America. (30)Nutrition and Metabolic Diseases Unit, Health Sciences Research Institute (IRSS), Bobo-Dioulasso, Burkina Faso. (31)Department of Nutrition, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America. BACKGROUND: Small vulnerable newborn (SVN) types, defined by combinations of being born too soon or too small, have distinct determinants, health consequences, and prevention strategies. The effects of prenatal balanced energy and protein (BEP) supplementation on SVN types remain unknown. METHODS AND FINDINGS: We conducted a systematic review and meta-analysis of individual participant data from eight randomized controlled trials of prenatal BEP supplements (N = 10,252, with 5,164 in the BEP arm and 5,088 in the control arm) in low- and middle-income countries were used. The control arms varied across studies and included context-specific standards of care, iron and folic acid supplements, or multiple micronutrient supplements. Newborns were classified into 10 groups through the combinations of preterm birth, small for gestational age (SGA) birth, and low birthweight (LBW), such as term-appropriate-for-gestational-age (AGA)-nonLBW, preterm-SGA-LBW, preterm-large-for-gestational-age-LBW, term-SGA-LBW, preterm-AGA-nonLBW, and other permutations. Newborns were also analyzed using a four-group categorization that included term-nonSGA, preterm-nonSGA, term-SGA, and preterm-SGA. Log-binomial models were used to estimate study-specific risk ratios (RRs), which were pooled using meta-analyses. Subgroup analyses were conducted by maternal age, parity, gestational age at enrollment, early pregnancy body mass index, and maternal anemia status. In the 10-group categorization of SVNs, on average, prenatal BEP supplementation led to a 30% lower risk of preterm-SGA-LBW (RR: 0.70; 95% CI [0.53, 0.91]; P = 0.009), a 25% lower risk of preterm-AGA-LBW (RR: 0.75; 95% CI [0.60, 0.93]; P = 0.009), and a 20% lower risk of term-SGA-LBW (RR: 0.80; 95% CI [0.72, 0.90]; P < 0.001). In the four-group categorization, prenatal BEP supplementation led to a 31% lower risk of preterm-SGA (RR: 0.69; 95% CI [0.52, 0.91]; P = 0.008) and a 12% lower risk of term-SGA (RR: 0.88; 95% CI [0.81, 0.96]; P = 0.005). The protective effect of prenatal BEP supplementation on preterm-SGA was stronger among multiparous women and women without anemia. The protective effects on all three SVN types under the four-group categorization were stronger among women enrolled before 20 weeks of gestation. The main limitations of the study included the absence of some BEP trials and the small event numbers for some SVN types. CONCLUSIONS: Prenatal BEP supplementation reduces the risk of SVNs to varying extents. Further research is needed to determine the optimal targeting approach for providing BEP supplements to vulnerable pregnant women who are most likely to benefit from the supplementation. Copyright: © 2026 Wang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. DOI: 10.1371/journal.pmed.1004716 PMCID: PMC12912696 PMID: 41701774 [Indexed for MEDLINE] Conflict of interest statement: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Authors employed by for-profit organizations: SKN is employed by Cytel Inc., India; VS is employed at DVPL Tech; BB is employed at Certara USA, Inc. All other authors declare no competing interests.

9.
Associations of antenatal micronutrient supplementation with adolescent blood pressure: evidence from a 14-year follow-up study of a randomized controlled trial.
BMC public health 2025 PMID:41275168

4. BMC Public Health. 2025 Nov 22;25(1):4421. doi: 10.1186/s12889-025-25672-y. Associations of antenatal micronutrient supplementation with adolescent blood pressure: evidence from a 14-year follow-up study of a randomized controlled trial. Feng H(#)(1)(2), Li X(#)(1), Shan J(#)(1), Zhu Y(1), Wang L(1), Huang L(1)(3), Wang X(1), Jingele X(1), Yan J(1), Liu Y(1), Li S(4), Nan L(5), Cheng Y(6), Zeng L(#)(7)(8)(9), Zhu Z(#)(10)(11)(12). Author information: (1)Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, No.76, Yanta West Road, Xi'an, Shaanxi, 710061, P.R. China. (2)Department of Child Health Care, Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an, Shaanxi, 710004, P. R. China. (3)Department of Human Resources, Xingyi People's Hospital, 1 Yingxiong Road, Xingyi, 562400, P. R. China. (4)Department of Experimental Teaching Center, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China. (5)The First Affiliated Hospital of Xi'an Jiaotong University, 277 Yanta West Road, Xi'an, 710061, P. R. China. (6)Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, 710061, Shaanxi, P.R. China. (7)Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, No.76, Yanta West Road, Xi'an, Shaanxi, 710061, P.R. China. tjzlx@mail.xjtu.edu.cn. (8)Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Xi'an, P. R. China. tjzlx@mail.xjtu.edu.cn. (9)Center for Chronic Disease Control and Prevention, Global Health Institution, Xi'an Jiaotong University, Xi'an, P. R. China. tjzlx@mail.xjtu.edu.cn. (10)Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, No.76, Yanta West Road, Xi'an, Shaanxi, 710061, P.R. China. zhuzhonghai@hotmail.com. (11)Key Laboratory for Disease Prevention and Control and Health Promotion of Shaanxi Province, Xi'an, P. R. China. zhuzhonghai@hotmail.com. (12)Center for Chronic Disease Control and Prevention, Global Health Institution, Xi'an Jiaotong University, Xi'an, P. R. China. zhuzhonghai@hotmail.com. (#)Contributed equally BACKGROUND: This study directly examined the effects of antenatal micronutrient supplementation on adolescent blood pressure (BP). METHODS: This study involved adolescents from two rural counties in western China. Their mothers had previously participated in a cluster-randomized trial of antenatal micronutrient supplementation. All pregnant women were randomized to take a daily capsule of folic acid (FA) as control, folic acid plus iron (IFA), or multiple micronutrients (MMNs) until delivery. Adolescent BP was assessed using a validated electronic sphygmomanometer and converted into percentiles by population reference. We examined the effects of antenatal micronutrient supplementation on adolescent BP and BP percentiles using generalized estimation equations. Multinomial logistic regression was employed to examine the associations between antenatal micronutrient supplementation and categorical BP outcomes, with relative risk reduction estimated. RESULTS: Among 4488 singleton births eligible for long-term follow-up, 1994 (44.4%) adolescents were followed, and among them, 59.2% were male, with a mean age of 11.73 (SD, 0.86) years old. After adjusting for a range of covariates, antenatal MMNs supplementation relative to FA alone was associated with a 1.13 (95% CI -2.09, -0.17) mmHg lower systolic blood pressure (SBP) and a 2.59 (95% CI -5.01, -0.17) points lower SBP percentile. The similar benefits of MMNs were observed for categorized adolescent high BP (SBP and/or diastolic blood pressure (DBP) ≥ the 95th percentile for age, sex, and height). CONCLUSIONS: Compared with folic acid alone, antenatal MMNs supplementation was associated with lower adolescent SBP. This finding suggests that comprehensive antenatal nutritional interventions may offer a potential strategy for the primordial prevention of hypertension in offspring. TRIAL REGISTRATION: ISRCTN08850194, retrospectively registered December 14, 2006. https://www.isrctn.com/ISRCTN08850194?q=ISRCTN08850194&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10 . © 2025. The Author(s). DOI: 10.1186/s12889-025-25672-y PMCID: PMC12754940 PMID: 41275168 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: All human studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The relevant laws of China were followed during the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

10.
Non-inferiority Assessment of Maternal Adherence to Supplements, a Trial on the Effects of Multiple Micronutrient Supplementation (NAMASTE-MMS) in Nepal: study protocol.
Trials 2025 PMID:41233886

5. Trials. 2025 Nov 13;26(1):502. doi: 10.1186/s13063-025-09031-1. Non-inferiority Assessment of Maternal Adherence to Supplements, a Trial on the Effects of Multiple Micronutrient Supplementation (NAMASTE-MMS) in Nepal: study protocol. Cunningham K(1), Poudel S(2), Hoang MA(1), Gupta AS(3), Adhikari R(3), K C D(3), Mohan D(4), Rana Y(5), Lal BK(6), Thapa LB(6), Klemm R(1). Author information: (1)Helen Keller Intl, New York, USA. (2)Helen Keller Intl, Kathmandu, Nepal. SPoudel2@hki.org. (3)Helen Keller Intl, Kathmandu, Nepal. (4)Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. (5)Eleanor Crook Foundation, Washington D.C., USA. (6)Ministry of Health and Population, Kathmandu, Nepal. BACKGROUND: Micronutrient deficiencies among pregnant women contribute to adverse maternal and neonatal outcomes. Multiple micronutrient supplementation (MMS) has proven its superiority when compared to the standard iron and folic acid (IFA) supplementation for maternal and infant morbidity and mortality. The Government of Nepal is exploring the scale-up of MMS, but first requires evidence such as on its adherence and acceptability. The objective of this study, thus, is to generate this needed evidence. METHODS: The Non-inferiority Assessment of Maternal Adherence to Supplements, a Trial on the Effects of Multiple Micronutrient Supplementation (NAMASTE-MMS) in Nepal study is a three-arm, parallel, non-inferiority cluster-randomized controlled trial (c-RCT) assessing how well pregnant women adhere to and accept different types of supplements: MMS in blister packs or bottles versus IFA in blister packs. In one of Nepal's seven provinces, Lumbini, the longitudinal NAMASTE-MMS study is being implemented across 120 health facilities (clusters), enrolling 2640 pregnant women into one of three arms: IFA-blister, MMS-blister, or MMS-bottle. The primary outcome is adherence to 180 supplements during pregnancy, measured by tablet counts with a non-inferiority margin of 13%. Secondary outcomes include comparisons of adherence between the two MMS arms and utilization of Antenatal Care (ANC), both potentially impacted by type of packaging. Exploratory outcomes include comparisons of adherence as well as the degree of acceptability to supplementation during early and mid pregnancy and post-partum. DISCUSSION: Evidence generated from this study and three related mixed-methods implementation research studies will help the government in its potential scale-up of MMS supplementation during pregnancy and lactation. TRIAL REGISTRATION: NCT06327646 (ClinicalTrials.gov, March 18, 2024 registered). © 2025. The Author(s). DOI: 10.1186/s13063-025-09031-1 PMCID: PMC12613700 PMID: 41233886 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate {24}: Ethical review and approval was obtained by the Nepal Health Research Council (95_2024). To ensure transparency and accountability, the trial was also registered on ClinicalTrials.gov (NCT06327646). Consent for publication {32}: All authors consent to submission for publication. Competing interests {28}: The principal investigator (SP) and co-principal investigator (KC) declare they have no competing interests.

11.
Effect of prenatal multiple micronutrient supplements and medium-quantity lipid-based nutritional supplements on maternal weight gain and infant birth weight in rural Niger: a cluster-randomised trial.
BMJ global health 2025 PMID:41184032

6. BMJ Glob Health. 2025 Nov 3;10(11):e021013. doi: 10.1136/bmjgh-2025-021013. Effect of prenatal multiple micronutrient supplements and medium-quantity lipid-based nutritional supplements on maternal weight gain and infant birth weight in rural Niger: a cluster-randomised trial. Rattigan SM(1), Garba S(2), Plikaytis B(3), Sudfeld C(4), Guindo O(2), Soumana I(2), Langendorf C(5), Grais R(5), Isanaka S(6)(5). Author information: (1)Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA. (2)Epicentre, Maradi, Niger. (3)BioStat Consulting, Jasper, Georgia, USA. (4)Global Health and Population, Harvard T H Chan School of Public Health, Boston, Massachusetts, USA. (5)Epicentre, Paris, France. (6)Department of Nutrition, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA sisanaka@hsph.harvard.edu. INTRODUCTION: The risk of adverse birth outcomes, such as low birth weight (<2500 g, LBW), is associated with poor maternal nutrition and weight gain in pregnancy and can increase the risk of infant mortality. We evaluated the effect of three prenatal nutritional supplementation strategies to improve maternal nutrition and adverse pregnancy and birth outcomes. METHODS: A cluster-randomised trial of three prenatal nutritional supplements was conducted in rural Niger. Villages (n=53) were randomised to receive either daily prenatal multiple micronutrient supplementation with 20 micronutrients and 30 mg iron (MMN), medium-quantity lipid-based micronutrient supplementation with 30 mg iron and 237 kcal (MQ-LNS), or routine iron folic acid supplementation with 60 mg of iron (IFA). Pregnant women were identified through monthly, community-based pregnancy surveillance. Study outcomes included infant birth weight, maternal weight gain during pregnancy (including total weight gain, rate of weight gain and adequacy of weight gain) and maternal haemoglobin (Hb) concentration and anaemia (Hb <110 g/L) in the second and third trimesters. RESULTS: A total of 3332 pregnant women were enrolled between September 2015 and February 2017. Birth weight did not significantly differ by supplementation group (mean difference MMN vs IFA=39 g, 95% CI -55, 134; mean difference MQ-LNS vs IFA=50 g, 95% CI -55, 156). There was also no statistically significant effect of MMN or MQ-LNS compared with IFA on total weight gain in pregnancy, the rate of weight gain per week during the second and third trimesters or adequacy of gestational weight gain (p values >0.05). We found no effect of MMN or MQ-LNS on maternal haemoglobin concentration or anaemia in the second and third trimesters (p values >0.05). CONCLUSION: There was no statistically significant difference in birth weight, maternal weight gain or anaemia by prenatal nutritional supplementation strategy. However, statistical power in the trial was limited. A combination of strategies may be required to make large improvements in birth and pregnancy outcomes in rural Niger. © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. DOI: 10.1136/bmjgh-2025-021013 PMCID: PMC12606480 PMID: 41184032 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: None declared.

12.
The effect of facility-based nutrition education and counseling on dietary intake and supplemental iron folic acid use among pregnant women: a cluster randomised controlled trial.
Public health nutrition 2025 PMID:41178447

7. Public Health Nutr. 2025 Nov 3;28(1):e191. doi: 10.1017/S1368980025101304. The effect of facility-based nutrition education and counseling on dietary intake and supplemental iron folic acid use among pregnant women: a cluster randomised controlled trial. Mohammedsanni A(1), Haile D(1), Endris BS(1), Gebrehiwot Y(2), Kassahun EA(1), Gebreyesus SH(1). Author information: (1)Department of Nutrition and Dietetics, School of Public Health, https://ror.org/038b8e254College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. (2)Department of Obstetrics and Gynecology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. OBJECTIVE: Nutrition education plays a crucial role in improving the nutritional status of pregnant women, yet evidence of its impact in low-income settings like Ethiopia is limited. This study evaluated the effectiveness of facility-based nutrition education and counseling on pregnant women's knowledge, dietary practices, and Fe-folic acid supplement use. DESIGN: A cluster randomised controlled trial was conducted in Addis Ababa, Ethiopia, involving 683 pregnant women across twenty health centres assigned to intervention or control groups. Antenatal care providers in the intervention group received training on pregnancy nutrition and counseling, while the control group continued standard care per national guidelines. A total of 683 pregnant women were enrolled during their first and second antenatal care (ANC) visits. Mixed-effects linear regression was used to evaluate outcomes. STUDY SETTING: The study was conducted in Addis Ababa, Ethiopia, from August to December 2017. PARTICIPANTS: Pregnant women attending ANC follow-ups and healthcare providers working in ANC units. RESULTS: The intervention group demonstrated significant improvements in knowledge, including iodised salt use (difference-in-differences (DID) 23 %), correct Fe-folic acid supplementation duration (DID 68 %) and the need for additional meals during pregnancy (DID 49·9 %). Dietary practices improved with higher dietary diversity (DID 32·3 %), increased dairy consumption (MD 1·2 v. -0·1; DID 1·2 per week) and higher Fe-folic acid supplementation (MD 4·9 v. 1·6; DID 3·2 per week). CONCLUSION: Nutrition education and counseling during ANC visits significantly improved pregnant women's knowledge and dietary practices. Integrating and strengthening these interventions into routine ANC services could effectively enhance dietary intake and health outcomes. DOI: 10.1017/S1368980025101304 PMCID: PMC12722067 PMID: 41178447 [Indexed for MEDLINE] Conflict of interest statement: The authors declare that there are no conflicts of interest regarding the research, authorship or publication of this study. All procedures and outcomes have been conducted impartially and without any financial or personal interests that could influence the results or interpretation of the data.

13.
Prenatal and preschool micronutrient supplementation and behavioral outcomes in school-aged children in Nepal-a cohort study.
The American journal of clinical nutrition 2025 PMID:41092983

8. Am J Clin Nutr. 2025 Dec;122(6):1788-1796. doi: 10.1016/j.ajcnut.2025.10.006. Epub 2025 Oct 13. Prenatal and preschool micronutrient supplementation and behavioral outcomes in school-aged children in Nepal-a cohort study. Christian P(1), Zavala E(2), Hurley KM(2), Khatry SK(3), LeClerq SC(3), Fune Wu LS(2), Tielsch JM(4), Katz J(2), Murray-Kolb LE(5). Author information: (1)Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States. Electronic address: pchrist1@jhu.edu. (2)Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States. (3)Nepal Nutrition Intervention Project, Sarlahi, Nepal. (4)Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington DC, United States. (5)Department of Nutrition Science, College of Health and Human Sciences, Purdue University, West Lafayette, IN, United States. BACKGROUND: A few studies examined behavioral difficulties among children in low-income countries or the influence of early life nutrition interventions. OBJECTIVES: We examined the effect of micronutrient supplementation done as part of 2 randomized trials during pregnancy or in early preschool age on behavioral outcomes among school-aged children in rural Nepal. METHODS: Children between 7 and 9 y of age were enrolled in a cohort follow-up study in which the Conners Rating Scale-Revised was administered to their parents and teachers. These children were offspring of participants in a cluster-randomized trial during pregnancy receiving daily iron-folic acid, iron-folic acid + zinc, or multiple micronutrients, compared with a control (all groups received vitamin A). These children between 12 and 35 mo of age also received daily placebo, iron-folic acid, zinc alone, or iron-folic acid + zinc in a separate randomized trial. Factor analysis identified 2 attention-deficit hyperactivity disorder-related behaviors for parent scores (hyperactivity/oppositional and inattention) and 2 for teacher scores (hyperactivity and inattention). Using mixed-effects linear regression analysis, we analyzed the effect of early life supplementation on these behavioral domains in school children (n = 1255). RESULTS: Exposure to prenatal iron-folic acid resulted in lower oppositionality/hyperactivity and inattention scores in children assessed via parental ratings in both unadjusted and adjusted analyses. Iron-folic acid with zinc reversed the positive effect seen with iron-folic acid. Multiple micronutrient supplementation resulted in a lower oppositionality and/or hyperactivity score, using parent and teacher ratings in the adjusted analysis. All 3 supplement groups in the preschool trial reduced child inattention when assessed by parents. Based on teacher ratings, groups that had received iron-folic acid alone or with zinc during preschool had reduced scores of hyperactivity in both unadjusted and adjusted analyses. CONCLUSIONS: Our study shows potential benefit of early life exposure to micronutrient supplementation for child-related behavior outcomes in a South Asian setting where inadequate diets and nutrition deficiencies exist. Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.ajcnut.2025.10.006 PMCID: PMC12710460 PMID: 41092983 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest PC served as associate editor for the American Journal of Clinical Nutrition. All other authors report no conflicts of interest.

14.
The Efficacy of Zinc Supplementation Alone or in Combination for Improving Pregnancy and Infant Outcomes: A Systematic Review and Meta-Analysis.
Journal of evidence-based medicine 2025 PMID:40836314

9. J Evid Based Med. 2025 Sep;18(3):e70061. doi: 10.1111/jebm.70061. Epub 2025 Aug 20. The Efficacy of Zinc Supplementation Alone or in Combination for Improving Pregnancy and Infant Outcomes: A Systematic Review and Meta-Analysis. Diao S(1)(2)(3)(4)(5), Feng Y(6), Peng X(3)(7), Liu D(1)(2)(3)(4), Huang L(1)(2)(3)(4), Zeng L(1)(2)(3)(4)(8), Zhang L(1)(2)(3)(4)(5)(8). Author information: (1)Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China. (2)Children's Medicine Key Laboratory of Sichuan Province, Chengdu, Sichuan, China. (3)Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, Sichuan, China. (4)NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, Chengdu, Sichuan, China. (5)Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. (6)West China School of Pharmacy, Sichuan University, Chengdu, Sichuan, China. (7)Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China. (8)West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. OBJECTIVE: To evaluate zinc supplementation's efficacy in pregnancy, addressing gaps in previous reviews regarding high-risk subgroups and combination therapies. METHODS: Systematic review of six databases through March 27, 2025 for randomized controlled trials (RCTs) on prenatal zinc supplementation. Risk of bias was assessed using the Cochrane Risk of Bias 2. Stratified analyses was conducted by participant or intervention characteristics, with meta-analysis or qualitative synthesis when appropriate. Sensitivity analyses was conducted by excluding studies with high risk of bias. The systematic review was registered in PROSPERO (CRD42023440314). RESULTS: 77 RCTs were included. Compared with no zinc, zinc monotherapy among healthy pregnant women resulted in higher serum zinc level (standard mean difference (SMD) the second trimester = 0.32, 95% confidence interval (CI) 0.20 to 0.44; SMDthe third trimester = 0.51, 95% CI 0.27 to 0.76), lower fetal intrauterine retardation rate (risk ratio = 0.23, 95% CI 0.16 to 0.35), longer neonatal birth length (SMD = 0.66, 95% CI 0.21 to 1.12), bigger birth head circumference (SMD = 0.58, 95% CI 0.08 to 1.09), higher 1-min Apgar score (SMD = 0.28, 95% CI 0.06 to 0.49) and cord blood zinc level (SMD = 0.36, 95% CI 0.17 to 0.56). No additional benefits observed with zinc-iron-folate combinations versus iron-folate alone. Qualitative synthesis of limited evidence suggested potential benefits for high-risk groups (anemia, gestational diabetes, zinc deficiency or impaired intravenous glucose tolerance test). CONCLUSIONS: Zinc monotherapy may benefit healthy pregnancies and high-risk groups, but combination regimens show no additional advantages. Further research should confirm these findings. © 2025 The Author(s). Journal of Evidence‐Based Medicine published by Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd. DOI: 10.1111/jebm.70061 PMCID: PMC12506952 PMID: 40836314 [Indexed for MEDLINE] Conflict of interest statement: The authors declare that they have no competing interests.

15.
The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study.
BMJ global health 2025 PMID:40533249

10. BMJ Glob Health. 2025 Jun 18;10(6):e016264. doi: 10.1136/bmjgh-2024-016264. The impact of enhancing nutrition and antenatal infection treatment on birth outcomes in Amhara, Ethiopia: a pragmatic factorial, cluster-randomised clinical effectiveness study. Lee AC(1)(2), Workneh F(3), Kang Y(4), Yibeltal K(5), Fasil N(6), Tsegaye S(7), Baye E(2), Kidane WT(7), Berhane YY(3), Derebe MM(8), Van Dyk F(4), Eglovitch M(2), Olson I(2), Mengistie MM(8), Shiferie F(3), Shifraw T(5), Lu C(9)(10), North K(2)(9), Chan GJ(11)(12), Isanaka S(13), Molina RL(9)(14), Tadesse AW(7)(15), Wylie BJ(14), Christian P(4), Mullany LC(4), Worku A(3), Berhane Y(3). Author information: (1)Department of Pediatrics, Brown University, Providence, Rhode Island, USA anne_cc_lee@brown.edu. (2)Department of Pediatrics, Brigham and Women's Hospital, Boston, Massachusetts, USA. (3)Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (4)Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. (5)Department of Reproductive Health and Population, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (6)Department of Global Health and Health Policy, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (7)Department of Nutrition and Behavioral Science, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (8)Amhara Public Health Institute, Bahir Dar, Ethiopia. (9)Harvard Medical School, Boston, Massachusetts, USA. (10)Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA. (11)Department of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA. (12)Children's Hospital of Philadelphia, Philadelphia, PA, USA. (13)Departments of Nutrition and Global Health and Population, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA. (14)Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. (15)Department of Infectious Disease Epidemiology and International Health, London School of Hygiene & Tropical Medicine, London, UK. INTRODUCTION: We aimed to determine the impact of antenatal interventions to optimise maternal nutrition and infection management on birth outcomes in Ethiopia. METHODS: We conducted a pragmatic, open-label, 2×2 factorial randomised clinical effectiveness study among pregnant women enrolled <24 weeks gestation in 12 rural health centres in Amhara, Ethiopia. Eligible health centres were randomised to deliver an enhanced nutrition package (ENP) (iron-folic acid, iodised salt and targeted micronutrient fortified balanced energy protein (BEP) supplementation for undernourished women) or routine nutrition care (iron-folic acid only). Individual women were randomised to receive an enhanced infection management package (EIMP) (genitourinary tract infection screening-treatment and enhanced deworming) or routine infection care (syndromic management). The primary outcomes were birth weight and length; secondary outcomes were gestational age, preterm delivery, small-for-gestational-age, low birth weight, stillbirth, newborn weight-for-age and length-for-age z-scores, newborn head circumference, and maternal anemia. Analysis was intention to treat. RESULTS: From August 2020 to December 2021, 2392 women were randomised (604 ENP+EIMP, 600 ENP alone, 593 EIMP alone and 595 neither package) and followed until June 2022, with 2170 pregnancy outcomes analysed (565 ENP+EIMP, 549 ENP, 525 EIMP, 531 neither). In the ENP arm, 427 (36%) women were eligible for BEP and consumed on average 74 days. The prevalence of genitourinary tract infection was low (4.9%), while parasitic stool infections were common (31%). There was no difference in birth weight (ENP vs not-ENP: adjusted mean difference -4 g (-83 to 75); EIMP vs not-EIMP: 18 g (-35 to 70); ENP+EIMP vs neither: 14 g (-81 to 109)) or birth length (ENP: -0.3 cm (-1.1 to 0.5); EIMP: 0.2 cm (-0.1 to 0.5); ENP+EIMP: -0.1 cm (-1.2 to 1.1)) between study arms. In the ENP+EIMP group, the stillbirth rate was lower compared with the arm receiving neither package (7.1/1000 vs 24.7/1000 births; adjusted relative risk: 0.29 (0.09 to 0.94)). The packages did not significantly affect other secondary outcomes. CONCLUSIONS: In this pragmatic study implemented within the Ethiopian health system, enhanced nutrition and infection packages did not affect birth weight or length. While stillbirth rates were lower in the group receiving both packages, these findings need to be supported by additional studies. TRIAL REGISTRATION NUMBER: ISRCTN15116516. © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. DOI: 10.1136/bmjgh-2024-016264 PMCID: PMC12181995 PMID: 40533249 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: ACCL received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5K23HD091390), WHO and Johns Hopkins University. All other authors declare no competing interests.

16.
Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy.
Trials 2025 PMID:40517226

11. Trials. 2025 Jun 14;26(1):206. doi: 10.1186/s13063-025-08906-7. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Smith ER(#)(1), Muhihi A(#)(2), Wylie BJ(3), Mugusi S(4), Aboud S(5)(6), Bakari M(7), Fawzi W(8), Kinyogoli S(2), Oakley EM(9), Pan Q(10), Sando MM(2), Brownlee VS(9), Pembe AB(#)(11), Sudfeld CR(#)(8), Masanja H(#)(12). Author information: (1)Department of Global Health, The Milken Institute School of Public Health, The George Washington University, Washington, D.C. 20053, USA. emilysmith@gwu.edu. (2)Africa Academy for Public Health, Dar Es Salaam, Tanzania. (3)Columbia University Medical School, Columbia University, New York, NY, 10032, USA. (4)Department of Clinical Pharmacology, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. (5)Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. (6)National Institute for Medical Research, Dar Es Salaam, Tanzania. (7)Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. (8)Harvard University T.H. Chan School of Public Health, Harvard University, Boston, MA, 02115, USA. (9)Department of Global Health, The Milken Institute School of Public Health, The George Washington University, Washington, D.C. 20053, USA. (10)Department of Statistics, Columbian College of Arts & Science, The George Washington University, Washington, D.C. 20053, USA. (11)Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania. (12)Ifakara Health Institute, Dar Es Salaam, Tanzania. (#)Contributed equally BACKGROUND: Antenatal multiple micronutrient supplementation (MMS) has been shown to be more effective than iron-folic acid (IFA) alone in reducing adverse pregnancy and birth outcomes. However, there is a concern that MMS containing 30 mg of iron may be less effective in reducing maternal anemia compared to IFA supplements containing 60 mg of iron. This poses a clinical and programmatic dilemma for countries with a high burden of maternal anemia (> 40% prevalence) where the World Health Organization (WHO) recommends using IFA with 60 mg of iron. METHODS/DESIGN: We will conduct an individually randomized, quadruple-blind superiority trial of daily antenatal MMS in Dar es Salaam, Tanzania (n = 6381 pregnant women). Participants will be randomized to receive a daily MMS regimen during pregnancy containing 60 mg iron, 45 mg iron, or 30 mg iron at a ratio of 1:1:1. The trial participants, outcome assessors (research staff and care providers), investigators, trial statistician, and data analysts will be blinded. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized MMS regimen from enrollment until the time of pregnancy outcome/delivery. The primary outcome is maternal third-trimester moderate or severe anemia (Hb < 10.0 g/dL). The proportion of women who have moderate or severe anemia at 32 weeks of gestation will be compared between MMS containing 60 mg iron versus MMS containing 30 mg iron, as well as MMS containing 45 mg iron versus MMS containing 30 mg iron. Secondary outcomes include maternal hemoglobin concentration, anemia, maternal iron deficiency, and maternal iron deficiency anemia at 32 weeks gestation and 6 weeks postpartum; preeclampsia, antepartum bleeding, postpartum hemorrhage, maternal peripartum infection, pregnancy-related death, symptoms consistent with depression, fatigue, and maternal malaria during pregnancy and 42 days following; fetal death, stillbirth, birth weight, low birthweight, gestational age at birth, preterm birth, birthweight for gestational age, and small-for-gestational age birth; infant hemoglobin concentrations, infant iron status, neonatal death, and infant death at 6 weeks of age; and maternal side effects. Relative risks for binomial outcomes and mean differences for continuous outcomes and their 95% confidence intervals will be calculated for all the primary and secondary outcomes. DISCUSSION: This study will produce causal evidence on whether MMS containing 60 or 45 mg of iron is superior to MMS containing 30 mg of iron in reducing maternal anemia and improving other important maternal and infant health outcomes. The findings of this study will inform Tanzania and similar contexts on the optimal formulation of MMS as many countries begin transitioning from IFA to MMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT06079918. Registered on 2023-10-06. TRIAL STATUS: The trial is recruiting. We report protocol version 1.7 dated March 2, 2025. Recruitment started with the first patient enrolled on March 3, 2025. At the submission of this manuscript on April 10, 2025, 111 participants have been randomized. Recruitment is ongoing and should be completed by December 2026. © 2025. The Author(s). DOI: 10.1186/s13063-025-08906-7 PMCID: PMC12166632 PMID: 40517226 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board (Ref. No. IRB22-1581), Columbia University Medical Center (IRB-AAAU7271), the Ifakara Health Institute Institutional Review Board (IHI/IRB/No: 45–2023), the Muhimbili University of Health and Allied Sciences Institutional Review Board (MUHAS-REC-07–2023-1801), the National Health Research Ethics Committee (NatHREC) (Ref. No. NIMR/HQ/R.8a/Vol. IX/4448), Tanzania Commission for Science and Technology (COSTECH) (Permit No. CST00000303-2024–2024-00342) and the Tanzania Medicine and Medical Device Authority (TMDA) (Ref No. BC.69/96/98/01). All participants will provide written informed consent before enrollment into the trial and will have the right to withdraw at any time. Consent for publication: Not applicable. Competing interests: No competing interests to report for any authors or trial staff members.

17.
Contribution of Maternal Adherence to the Effect of Multiple Micronutrient Supplementation During Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis.
Advances in nutrition (Bethesda, Md.) 2025 PMID:40451462

12. Adv Nutr. 2025 Jul;16(7):100455. doi: 10.1016/j.advnut.2025.100455. Epub 2025 May 30. Contribution of Maternal Adherence to the Effect of Multiple Micronutrient Supplementation During Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis. Smith ER(1), Gomes F(2), Adu-Afarwuah S(3), Aguayo VM(4), El Arifeen S(5), Bhutta ZA(6), Caniglia EC(7), Christian P(8), Devakumar D(9), Dewey KG(10), Fawzi WW(11), Friis H(12), Gomo E(13), Guindo O(14), Hallamaa L(15), Isanaka S(16), Kæstel P(12), Lachat C(17), Maleta K(18), Moore SE(19), Oakley EM(20), Osrin D(9), Rahman A(5), Rana Z(21), Rizvi A(22), Roberfroid D(23), Shaikh S(24), Sonko B(25), Soofi SB(26), Subarkah I(27), Sunawang R(27), Wang D(28), West KP Jr(8), Wu LSF(8), Zagre N(29), Bourassa MW(30), Sudfeld CR(11). Author information: (1)Department of Global Health, Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States. (2)Nutrition Science Program, The New York Academy of Science, New York, NY, United States; NOVA Medical School, Universidade NOVA de Lisboa, Lisboa, Portugal; Healthy Mothers Healthy Babies Program, Micronutrient Forum, Washington, DC, United States. (3)Department of Nutrition and Food Science, University of Ghana, Legon, Accra, Ghana. (4)Child Nutrition and Development, UNICEF, New York, NY, United States. (5)Maternal and Child Health Division, International Centre for Diarrhoeal Diseases Research Bangladesh (ICDDR,B), Dhaka, Bangladesh. (6)Center of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan; Department of Pediatrics & Child Health, The Aga Khan University, Karachi, Pakistan; Institute of Global Health & Development, The Aga Khan University, Karachi, Pakistan. (7)Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States. (8)Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States; The JiVitA Project, Johns Hopkins University in Bangladesh, Gaibandha, Bangladesh. (9)Institute for Global Health, University College London, London, United Kingdom. (10)Department of Nutrition and Institute for Global Nutrition, University of California, Davis, Davis, CA, United States. (11)Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, United States. (12)Department of Nutrition Exercise and Sports, University of Copenhagen, Copenhagen, Denmark. (13)College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe. (14)Epicentre, Maradi, Niger. (15)Center for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland. (16)Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United States; Epicentre, Paris, France. (17)Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium. (18)School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi. (19)Department of Women & Children's Health, King's College London, London, United Kingdom; Medical Research Council Unit the Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia. (20)Department of Global Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, United States. (21)Nutrition Science Program, The New York Academy of Science, New York, NY, United States. (22)Department of Pediatrics & Child Health, The Aga Khan University, Karachi, Pakistan; Institute of Global Health & Development, The Aga Khan University, Karachi, Pakistan. (23)Department of Medicine, Namur University, Namur, Belgium. (24)The JiVitA Project, Johns Hopkins University in Bangladesh, Gaibandha, Bangladesh. (25)Medical Research Council Unit the Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia. (26)Center of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan; Department of Pediatrics & Child Health, The Aga Khan University, Karachi, Pakistan. (27)Center for Health Research, School of Public Health, University of Indonesia, Depok, Indonesia. (28)Department of Global and Community Health, College of Public Health, George Mason University, Fairfax, VA, United States. (29)Regional Office for West and Central Africa, UNICEF, Dakar, Senegal. (30)Nutrition Science Program, The New York Academy of Science, New York, NY, United States. Electronic address: mwbourassa@gmail.com. Erratum in Adv Nutr. 2025 Dec;16(12):100553. doi: 10.1016/j.advnut.2025.100553. Multiple micronutrient supplements (MMS) in pregnancy reduces risk of infant low birthweight (LBW) and improves other maternal and infant outcomes compared with iron and folic acid (IFA) supplements alone. However, the impact of timing of initiation and adherence on the MMS effectiveness in real-world programs remains unclear. To address this, we conducted a 2-stage individual participant data meta-analysis that included 15 randomized trials (61,204 pregnant women) and assessed whether the relative effect of MMS differed by the following: adherence alone; adherence in combination with gestational age at initiation; and the total number of tablets taken. We also evaluated the observational association of these factors with outcomes among participants who received MMS. Compared with IFA supplements, the relative effect of MMS on the primary outcome of continuous birthweight was greater with higher adherence (P-interaction < 0.05). Among women who took ≥90% of supplements, MMS increased birthweight by 56 g (95% CI: 45, 67 g), whereas among women who took <60% of supplements, there was no difference in birthweight between MMS and IFA supplements [mean difference (MD): 9 g; 95% CI: -17, 35 g). Higher adherence was also associated with greater effect of MMS on LBW and birthweight-for-gestational age centile and women who took more supplements experienced a greater relative impact of MMS on birthweight-for-gestational age centile and small-for-gestational age births (SGA) as compared with IFA supplements. Observational analyses among participants who received MMS showed that ≥90% adherence was associated with increased birthweight (MD: 44 g; 95% CI: 31, 56 g) and lower risk of LBW [relative risk (RR): 0.93 g; 95% CI: 0.88, 0.98 g] and small-for-gestational age (RR: 0.95; 95% CI: 0.93, 0.98), whereas <75% adherence was associated with greater risk of stillbirth (RR: 1.43; 95% CI: 1.12, 1.83) and maternal anemia (RR: 1.26; 95% CI: 1.11, 1.43) than 75%-90% adherence. Programs should invest in strategies that promote early initiation and high adherence to MMS. This trial was registered at PROSPERO as CRD42022319207. Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.advnut.2025.100455 PMCID: PMC12268027 PMID: 40451462 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest MWB reports financial support was provided by JBJ Foundation. ZAB is an Editorial Board Member for Advances in Nutrition and played no role in the Journal’s evaluation of the manuscript. The other authors report no conflicts of interest.

18.
Assessing the adherence and acceptability to iron and folic acid compared with multiple micronutrient supplements during pregnancy: a cluster-randomized noninferiority trial in Cambodia.
The American journal of clinical nutrition 2025 PMID:40334750

13. Am J Clin Nutr. 2025 Jul;122(1):166-173. doi: 10.1016/j.ajcnut.2025.04.033. Epub 2025 May 5. Assessing the adherence and acceptability to iron and folic acid compared with multiple micronutrient supplements during pregnancy: a cluster-randomized noninferiority trial in Cambodia. Sauer C(1), Hoang MA(2), Kroeun H(3), Gupta AS(4), Ngik R(3), Sokchea M(3), Labonté JM(5), Chea M(6), Klemm R(7), Mishra A(8), Panicker A(8), Sokhal V(8), Karakochuk CD(9). Author information: (1)Food, Nutrition & Health, The University of British Columbia, Vancouver, BC, Canada; Healthy Starts, BC Children's Hospital Research Institute, Vancouver, BC, Canada. (2)Helen Keller International, New York, NY, United States. (3)Helen Keller International, Phnom Penh, Cambodia. (4)Helen Keller International, Lalitpur, Nepal. (5)Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Canada. (6)National Nutrition Program, Ministry of Health, Phnom Penh, Cambodia. (7)Helen Keller International, New York, NY, United States; International Health, John Hopkins Bloomberg School of Public Health, Baltimore, MD, United States. (8)Vitamin Angel Alliance, Santa Barbara, CA, United States. (9)Food, Nutrition & Health, The University of British Columbia, Vancouver, BC, Canada; Healthy Starts, BC Children's Hospital Research Institute, Vancouver, BC, Canada. Electronic address: crystal.karakochuk@ubc.ca. BACKGROUND: The Cambodian Ministry of Health is exploring transitioning from iron and folic acid (IFA) to multiple micronutrient supplements (MMS) during pregnancy and is seeking rigorous evidence to inform this policy change. OBJECTIVE: We aimed to assess the adherence and acceptability of MMS compared with IFA supplementation during pregnancy. METHODS: We conducted an open-label cluster-randomized noninferiority trial across 48 health centers in Cambodia. A total of 1546 healthy pregnant individuals (18-45 y) were recruited at their first antenatal care (ANC) visit (<14 weeks of gestation) and randomized to 1 of 3 arms at the health center level: 1) IFA for 90 d (IFA-90, n = 515), the current standard of care; 2) MMS for 180 d via 1 180-tablet bottle (MMS-180, n = 516); or 3) MMS for 180 d via 2 90-tablet bottles (MMS-90, n = 515). Our primary outcome was the noninferiority of adherence rates of MMS-180 compared with IFA-90, assessed by tablet counts and compared against a predefined noninferiority margin of -15%. Mixed-effects linear regression models were used to estimate the mean difference (95% confidence interval [95% CI]) in adherence rates. Our secondary outcomes included the mean difference in ANC attendance between the MMS groups and the acceptability of MMS across 6 domains. RESULTS: Overall, 88% of participants completed the trial, with high mean adherence rates across arms (91% for IFA-90, 95% for MMS-180, and 95% for MMS-90). The adjusted mean (95% CI) difference in adherence rates between MMS-180 and IFA-90 groups was 3.9% (1.7, 6.2). The adjusted mean (95% CI) difference in ANC visits for MMS-180 and MMS-90 groups was 0.0 (-0.1, 0.2) visits. The acceptability of MMS was positive (90%-100% "agreement" across 6 domains). CONCLUSIONS: Both IFA and MMS were highly acceptable, yet adherence to MMS was superior to IFA. These findings support the transition from IFA to MMS in Cambodia. This trial was registered at Clinicaltrials.gov as NCT05867836. Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.ajcnut.2025.04.033 PMCID: PMC12308091 PMID: 40334750 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest AM, AP., and VS. report a relationship with Vitamin Angel Alliance Inc that includes employment. CDK. reports a relationship with Helen Keller International that includes consulting or advisory, nonfinancial support, and travel reimbursement. All other authors report no conflicts of interest.

19.
Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutrition and Antenatal Infection Treatment (ENAT) randomised effectiveness study.
BMJ open 2025 PMID:40295129

14. BMJ Open. 2025 Apr 28;15(4):e098686. doi: 10.1136/bmjopen-2024-098686. Investigating biological mechanisms of adverse birth outcomes and early child development in Amhara, Ethiopia: protocol of biospecimen collection and analysis of the Enhancing Nutrition and Antenatal Infection Treatment (ENAT) randomised effectiveness study. Roy Paladhi U(1), Workneh F(2), Baye E(3), Derebe MM(4), Yibeltal K(5), Fasil N(6), Driker S(3), Van Dyk F(7), I Chin T(8), North K(3)(9), Jensen SKG(10), Christian P(7), Worku A(11), Berhane Y(11), Lee AC(8)(3)(9). Author information: (1)Brown University Division of Biology and Medicine, Providence, Rhode Island, USA unmesha_roypaladhi@brown.edu. (2)Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (3)Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. (4)Amhara Public Health Institute, Bahir Dar, Ethiopia. (5)Reproductive Health, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (6)Global Health and Health Policy, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. (7)Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. (8)Brown University Division of Biology and Medicine, Providence, Rhode Island, USA. (9)Harvard University, Boston, Massachusetts, USA. (10)Developmental Medicine, Boston Children's Hospital, Boston, Massachusetts, USA. (11)Addis Continental Institute of Public Health, Addis Ababa, Ethiopia. INTRODUCTION: Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days. METHODS AND ANALYSIS: The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. We cluster-randomised pregnant women (n=2399) to receive either a nutrition intervention (iron-folic acid (IFA), iodised salt and balanced energy-protein supplementation for women with mid-upper arm circumference <23 cm) or routine care (IFA only), and individually randomised women to an infection control intervention (genitourinary tract infection screening-treatment and screening-treatment of stool parasites) or routine care (syndromic approach). Participants were followed until 1 month postpartum. A subset of 532 women-infant dyads were consecutively enrolled in the biospecimen substudy from July 2021 to August 2022. Specimens were collected at enrolment (<24 weeks) and antenatal care follow-up (third trimester), and 1-6 months postdelivery. A subset of ENAT mother-infant dyads (n=462) was enrolled in the Longitudinal Infant Development and Growth study that followed infants until 24 months postpartum, from February 2023 to June 2024. We will determine the impact of ENAT interventions on micronutrient status, inflammation biomarkers and metabolomic and microbiome profiles. We will also determine the association of these profiles with birth outcomes and infant neurodevelopment. ETHICS AND DISSEMINATION: These studies were approved by the Institutional Review Boards of Addis Continental Institute of Public Health (ACIPH/IRB/002/2022) and Mass General Brigham (2023P000461). Results will be disseminated to international stakeholders via peer-reviewed journals and locally via strategic dissemination sessions. TRIAL REGISTRATION NUMBERS: ISRCTN15116516 and NCT06296238. © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. DOI: 10.1136/bmjopen-2024-098686 PMCID: PMC12039041 PMID: 40295129 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: ACL received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (5K23HD091390), World Health Organization, and Johns Hopkins University. All remaining authors confirm they do not have any conflicts of interest to report.

20.
Influence of mobile phone calls on the compliance of the recommended four antenatal care visits in Kisii County, Kenya: a cluster randomized control trial.
African health sciences 2024 PMID:40190544

15. Afr Health Sci. 2024 Dec;24(4):174-181. doi: 10.4314/ahs.v24i4.23. Influence of mobile phone calls on the compliance of the recommended four antenatal care visits in Kisii County, Kenya: a cluster randomized control trial. Malachi ZM(1), Kivuti-Bitok LW(2)(3), Karani AK(2), Cheptum JJ(4). Author information: (1)Department of Nursing, School of Health Sciences, Kisii University, Kenya. (2)Department of Nursing, College of Health Sciences, University of Nairobi, Kenya. (3)Kenyatta National Hospital. (4)Aga Khan University, Nairobi. BACKGROUND: Antenatal care attendance is still low in sub-Saharan countries. While mobile phones have shown to improve outcomes in maternal health services, there are few published studies on the use of mobile phone calls in antenatal care. OBJECTIVE: To determine the influence of mobile phone calls on pregnant women's completion of the recommended 4 ANC visits in Kisii County, Kenya. METHODOLOGY: 16 sub county health facilities (clusters) were randomly assigned to either intervention or routine care. A total of 160 pregnant women were recruited in their first antenatal care visit and followed up until delivery. The intervention involved calling mothers through their mobile phones to give health education on antenatal care every month until delivery. The primary outcome measure was the completion of the 4 recommended antenatal care (ANC) visits while secondary outcome measures were; women receiving iron and folate supplements, and completion of all recommended laboratory tests. RESULTS: 50% of the women in the intervention group and 35% in the control group completed the four recommended ANC visits. The intervention was not a significant predictor of women receiving iron and folate supplements, RR, 1.07 (0.93 - 1.25), p - value = 0.412. However, the intervention was associated with a 46% increase in women completing all required antenatal care laboratory investigations. CONCLUSION: The use of mobile phone calls in antenatal health education show promise in improving antenatal care attendance among pregnant women. © 2024 Malachi ZM et al. DOI: 10.4314/ahs.v24i4.23 PMCID: PMC11970179 PMID: 40190544 [Indexed for MEDLINE]

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