Phase 3
N=44,567
Antenatal Micronutrient Supplementation and Infant Survival
Infant Mortality · Preterm Birth · Low Birth Weight · Neonatal Mortality · Perinatal Mortality
Bottom Line
View on ClinicalTrials.gov: NCT00860470 ↗Enrolled (actual)
44,567
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Infant Mortality Through 6 mo of Age — 764; 741 participants — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iron (27 mg) - folic acid (600 ug) (Dietary_supplement); Multiple micronutrient (Dietary_supplement)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Sep 2012
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 |
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.
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
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.