CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44,567 enrolled
Drug / intervention
Iron (27 mg) - folic acid (600 ug) +1 moredietary
Likely dose
Iron (27 mg) - folic acid (600 ug)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00860470
NCT00860470Phase 3Completed
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Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Mar 12, 2009·Updated Oct 19, 2022

In Brief

A Phase 3 clinical trial evaluating Iron (27 mg) - folic acid (600 ug) and Multiple micronutrient for Infant Mortality and 4 related conditions. Completed, enrolled 44,567 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality, Perinatal Mortality
CountriesBangladesh, United States
CollaboratorsBill and Melinda Gates Foundation, United States Agency for International Development (USAID), Mahidol University, Johns Hopkins University, Beximco Pharmaceuticals Ltd., dsm-firmenich Switzerland AG

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2009
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 17.3 years ago

Interventions

Iron (27 mg) - folic acid (600 ug)dietary

Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.

Multiple micronutrientdietary

Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.