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Clinical Trials/NCT00115271
NCT00115271
Completed
Phase 3

Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Johns Hopkins Bloomberg School of Public Health0 sites5,000 target enrollmentJanuary 1999

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Low Birth Weight
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
5000
Primary Endpoint
Birth weight
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1999
End Date
May 2001
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Parul Christian

Professor

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

Outcomes

Primary Outcomes

Birth weight

3-month infant mortality

Secondary Outcomes

  • Infant morbidity
  • Maternal morbidity
  • Maternal nutritional status
  • Weight gain during pregnancy
  • Infant growth

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