Antenatal Micronutrient Supplementation and Infant Survival

Phase 3

Completed

• Conditions: Low Birth Weight; Preterm Birth; Infant Mortality; Neonatal Mortality; Perinatal Mortality
• Interventions: Dietary Supplement: Iron (27 mg) - folic acid (600 ug); Dietary Supplement: Multiple micronutrient

• Registration Number: NCT00860470
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed Description

Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a \~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2015-05-07
• Results First Submitted QC: 2015-05-07
• Results First Posted: 2015-05-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44567

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Iron (27 mg) - folic acid (600 ug)	Iron (27 mg) and folic acid (600 ug)
2	Multiple micronutrient	Multiple micronutrient

Primary Outcome Measures

Name	Time	Method
Infant Mortality Through 6 mo of Age	6-months post-birth	Infant Mortality to Age 6 months (180 days from birth)

Secondary Outcome Measures

Name	Time	Method
Post-neonatal Mortality	1-6 months post-birth	Risk of Post-neonatal Mortality (29th -180th day of life)
Neonatal Mortality	1 month post-birth	Neonatal Mortality (28 days of life)
Preterm Birth	Up to 37 weeks of gestation	Being born before 37 weeks of gestation
Very Pre-term	Between 27 and 33 weeks of gestation	Birth between 28 and 32 weeks of gestation
Small for Gestation Age	At delivery/birth	Small for Gestational Age defined as birth weight \<10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Extremely Pre-term	Up to 28 weeks of gestation	Birth before 28 weeks gestation
Moderate to Late Preterm	Between 31 and 38 weeks of gestation	Birth between 32 and 37 weeks gestation
Low Birth Weight	Measured at delivery/birth	Birth weight below 2500g
Still Birth Rates	24 weeks gestation to delivery	Stillbirth (born \>=24 weeks without breathing, crying, or moving limbs).

Trial Locations

Locations (2)

JiVitA Project Office; 🇧🇩 Rangpur, Gaibandha District, Bangladesh

Johns Hopkins School of Public Health; 🇺🇸 Baltimore, Maryland, United States