drugset / Trial / NCT07540130

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

NCT07540130 ↗

RandomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron Folic Acid Unknown 400 ug Oral
Comparator Iron Folic Acid Unknown 60 mg Oral
Subject Multiple micronutrient supplementation Unknown — Oral

Indications

No indication recorded.