Skip to content

Antenatal Micronutrient Supplementation and Birth Weight

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00115271
Enrollment
5000
Registered
2005-06-22
Start date
1999-01-31
Completion date
2001-05-31
Last updated
2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Mortality, Low Birth Weight, Nutritional Status, Pregnancy

Keywords

Micronutrients, Supplementation, Pregnancy, Birth weight, Infant mortality

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.

Interventions

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
Bill and Melinda Gates Foundation
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Birth weight
3-month infant mortality

Secondary

MeasureTime frame
Maternal nutritional status
Infant morbidity
Infant growth
Weight gain during pregnancy
Maternal morbidity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026