Phase 3 Completed N=44,567 Randomized Quadruple-blind Prevention

Antenatal Micronutrient Supplementation and Infant Survival

infant mortality · Preterm Birth · Low Birth Weight · neonatal mortality

Source: ClinicalTrials.gov NCT00860470 ↗

Enrolled (actual)

44,567

Serious AEs

0.0%

Results posted

May 2015

Primary outcomePrimary: Infant Mortality Through 6 mo of Age — 764; 741 participants — p=0.36

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Infant Mortality Through 6 mo of Age	764; 741	0.36
SECONDARY Neonatal Mortality	625; 626	0.78
SECONDARY Post-neonatal Mortality	139; 115	0.11
SECONDARY Still Birth Rates	716; 648	0.02 sig
SECONDARY Preterm Birth	2912; 2510	<0.001 sig
SECONDARY Extremely Pre-term	136; 106	0.03 sig
SECONDARY Very Pre-term	385; 291	<0.001 sig
SECONDARY Moderate to Late Preterm	2391; 2113	0.87
SECONDARY Low Birth Weight	4809; 4275	<0.001 sig
SECONDARY Small for Gestation Age	6479; 6405	0.13

Eligibility Criteria

Inclusion Criteria

Pregnant and consents to participate

Exclusion Criteria

Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00860470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.