Effectiveness of MMS Compared With IFS Among Pregnant Women in Bangladesh: an Experimental Study

NCT07540130 | Active Not Recruiting Phase 1

• 1 other identifier: IRB/NINS/2025/412
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

Brief Summary

Background Maternal undernutrition and micronutrient deficiencies remain highly prevalent in Bangladesh and contribute to maternal anaemia, low birth weight, preterm birth, and adverse neonatal outcomes. Although iron-folic acid supplementation (IFAS) is routinely provided through antenatal care services, it does not address the full spectrum of micronutrient deficiencies. Multiple micronutrient supplementation (MMS) has demonstrated superior outcomes in clinical trials; however, evidence from real-world programmatic settings in Bangladesh is limited. Methods and analysis This experimental study will be conducted from March 2025 to March 2026 through antenatal care platforms coordinated by the Institute of Public Health Nutrition (IPHN), with centralised laboratory analysis at the National Institute of Neurosciences \& Hospital (NINS\&H), Dhaka. Pregnant women will receive either MMS or IFAS according to routine service delivery. The primary outcome is infant birth weight. Secondary outcomes include maternal haemoglobin and micronutrient biomarkers, preterm birth, dietary diversity, and supplementation adherence. Quantitative data will be analysed using multivariable regression models in SPSS with adjustments for confounders and geographic clustering. A concurrent process evaluation will assess implementation, fidelity and acceptability. Ethics and dissemination Ethical approval has been obtained from the Institutional Review Board of NINS\&H. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, policy briefs, and stakeholder engagement workshops.

Conditions

Pregnant Women; Pregnant Women and Their Offspring

Keywords

multiple micronutrient supplementation; iron-folic acid supplementation; pregnant women; experimental protocol

Outcome Measures

Primary Outcomes (1)

• infant birth weight

  The primary study outcome is infant birth weight measured in grams within 24 hours of delivery using calibrated digital scales

  within 24 hours of delivery

Study Arms (2)

IFAS

ACTIVE COMPARATOR

Iron Folic Acid Supplementation

Drug: Iron Folic Acid alone - Placebo

MMS

EXPERIMENTAL

Multiple Micronutrient Supplementation

Drug: Multiple micronutrient supplementation

Interventions

Multiple micronutrient supplementation DRUG

DGDSSSSSHJKLGL

Also known as: UNIMMAP

MMS

Iron Folic Acid alone - Placebo DRUG

daghjkl

IFAS

Eligibility Criteria

• Age: 15 Years - 35 Years
• Gender Eligibility Details: This study will recruit only pregnant women who attend routine antenatal care visits. So eligibility to participate in the study according to their biological sex is limited by their gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants will be eligible if they meet all of the following:
• Confirmed pregnancy, preferably in the first trimester, with singleton pregnancy where feasible.
• Permanent residence within the selected study catchment areas and ability to remain in the study area throughout follow-up.
• Enrollment in IPHN-supported antenatal care or supplementation programs.
• Nutritional vulnerability identified through screening indicators (eg, MUAC, BMI, or hemoglobin).
• Willingness to receive MMS or IFAS supplementation as assigned by routine service delivery platforms.
• Provision of written informed consent (thumbprint with witness for illiterate participants).
• Planned facility-based delivery or verifiable delivery location.

You may not qualify if:

• Participants will be excluded if any of the following apply:
• Withdrawal of informed consent at any stage.
• Diagnosed chronic medical conditions likely to influence pregnancy outcomes or nutritional biomarkers (eg, diabetes, hypertension, thyroid disorders, thalassemia).
• Planned relocation outside the study area before completion of follow-up.
• High-risk pregnancy requiring specialized tertiary care at enrollment.
• Participation in another nutrition intervention or clinical trial during the study period.
• Multiple gestation pregnancies (eg, twins).

Sponsors & Collaborators

• National Institute of Neurosciences and Hospital, Dhaka: lead
• Directorate General of Health Services, Bangladesh: collaborator

Study Sites (1)

National Institute of Neurosciences & Hospital Dhaka, Bangladesh

Dhaka, Dhaka Division, 1207, Bangladesh

Location

Related Publications (13)

• Prentice AM, Ward KA, Goldberg GR, Jarjou LM, Moore SE, Fulford AJ, Prentice A. Critical windows for nutritional interventions against stunting. Am J Clin Nutr. 2013 May;97(5):911-8. doi: 10.3945/ajcn.112.052332. Epub 2013 Apr 3.

  PMID: 23553163 BACKGROUND

• Haider BA, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004905. doi: 10.1002/14651858.CD004905.pub2.

  PMID: 17054223 BACKGROUND

• Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4.

  PMID: 18206223 BACKGROUND

• National Institute of Population Research and Training (NIPORT), and ICF. 2020. Bangladesh Demographic and Health Survey 2017-18. Dhaka, Bangladesh, and Rockville, Maryland, USA: NIPORT and ICF.

  BACKGROUND

• Rahman S, Karim R, Jahan N. Community-based nutrition education and its impact on maternal and child health in Bangladesh. J Glob Health Res. 2022;10(2):101-115.

  BACKGROUND

• National Nutrition Services. Technical Advisory Group on multiple micronutrient supplementation in Bangladesh: policy framework and implementation guidance. Dhaka: Ministry of Health and Family Welfare; 2021.

  BACKGROUND

• Lattof SR, Moran AC, Kidula N, Moller AB, Jayathilaka CA, Diaz T, Tuncalp O. Implementation of the new WHO antenatal care model for a positive pregnancy experience: a monitoring framework. BMJ Glob Health. 2020 Jun;5(6):e002605. doi: 10.1136/bmjgh-2020-002605.

  PMID: 32565442 BACKGROUND

• Smith ER, Shankar AH, Wu LS, Aboud S, Adu-Afarwuah S, Ali H, Agustina R, Arifeen S, Ashorn P, Bhutta ZA, Christian P, Devakumar D, Dewey KG, Friis H, Gomo E, Gupta P, Kaestel P, Kolsteren P, Lanou H, Maleta K, Mamadoultaibou A, Msamanga G, Osrin D, Persson LA, Ramakrishnan U, Rivera JA, Rizvi A, Sachdev HPS, Urassa W, West KP Jr, Zagre N, Zeng L, Zhu Z, Fawzi WW, Sudfeld CR. Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health. 2017 Nov;5(11):e1090-e1100. doi: 10.1016/S2214-109X(17)30371-6.

  PMID: 29025632 BACKGROUND

• Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.

  PMID: 30873598 BACKGROUND

• Institute of Public Health Nutrition. National guidelines for iron and folic acid supplementation programme in Bangladesh. Dhaka: Ministry of Health and Family Welfare; 2013.

  BACKGROUND

• Ahmed T, Hossain M, Sanin KI. Global burden of maternal and child undernutrition and micronutrient deficiencies. Ann Nutr Metab. 2012;61 Suppl 1:8-17. doi: 10.1159/000345165. Epub 2013 Jan 21.

  PMID: 23343943 BACKGROUND

• Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

  PMID: 18207566 BACKGROUND

• Engle-Stone R, Kumordzie SM, Meinzen-Dick L, Vosti SA. Replacing iron-folic acid with multiple micronutrient supplements among pregnant women in Bangladesh and Burkina Faso: costs, impacts, and cost-effectiveness. Ann N Y Acad Sci. 2019 May;1444(1):35-51. doi: 10.1111/nyas.14132. Epub 2019 May 27.

  PMID: 31134641 RESULT

Study Officials

• Shah Golam Nabi, MBBS, MPHM

  National Institute of Neurosciences & Hospital, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding The study will be an open-label clinical trial where neither the pregnant women nor the research assistant will be blinded to the allocation of the UNIMAPS and IFS. After the computer-generated simple random sampling technique, the amount will be given by the research assistant with the prescribed amount.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sampling Frame The sampling frame will consist of all enrolled pregnant mothers in the MMS and IFAS cohorts who meet the inclusion criteria and complete baseline enrolment procedures. Sample Size for Biomarker Sub-study The biomarker sub-study will include a total of 600 pregnant mothers. * 300 MMS consumers * 300 IFAS consumers This sub-sample size is determined based on feasibility, budgetary constraints, and acceptable statistical precision for biomarker comparisons between groups. Sampling Method A stratified random sampling approach will be applied for the selection of sample collection sites. A simple random sampling method was applied for allocation of the drugs. intervention group (MMS vs IFAS). * Within each group, further stratification by district and upazila ensures geographic representation. * From each stratum, participants will be selected using computer-generated simple random sampling from the KoBo database.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 20, 2026
• Study Start: February 11, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)