Antenatal Micronutrient Supplementation and Birth Weight

Phase 3

Completed

• Conditions: Infant Mortality; Nutritional Status; Low Birth Weight; Pregnancy

• Registration Number: NCT00115271
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

Detailed Description

Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination.

Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2001-05
• Study Completion: 2001-05
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

• Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria

• Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Birth weight
3-month infant mortality

Secondary Outcome Measures

Name	Time	Method
Infant morbidity
Maternal nutritional status
Weight gain during pregnancy
Infant growth
Maternal morbidity