Clinical Trial

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

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated April 29, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-13.
Trial Details
NCT Number NCT07540130
Lead Sponsor National Institute of Neurosciences and Hospital, Dhaka
Collaborators: Directorate General of Health Services, Bangladesh
Conditions Pregnant Women, Pregnant Women and Their Offspring
Enrollment 667 participants
Start Date 2025-02-11
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-29