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

NCT07540130 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

DRUG

Multiple micronutrient supplementation

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DRUG

Iron Folic Acid alone - Placebo

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Sponsors & Collaborators

  • Directorate General of Health Services, Bangladesh

    collaborator OTHER_GOV

  • National Institute of Neurosciences and Hospital, Dhaka

    lead OTHER_GOV

Principal Investigators

  • Shah Golam Nabi, MBBS, MPHM · National Institute of Neurosciences & Hospital, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540130 on ClinicalTrials.gov