Antenatal Micronutrient Supplementation and Birth Weight

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115271
• Other study ID #: H.22.98.09.02.C1
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2005
• Last updated: August 22, 2014
• Start date: January 1999
• Est. completion date: May 2001

Study information

• Verified date: August 2014
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: May 2001
• Est. primary completion date: May 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Infant Mortality
• Low Birth Weight
• Nutritional Status
• Pregnancy

Intervention

Drug:
• Nutritional supplements

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Johns Hopkins University, United States Agency for International Development (USAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight
Primary	3-month infant mortality
Secondary	Infant morbidity
Secondary	Maternal morbidity
Secondary	Maternal nutritional status
Secondary	Weight gain during pregnancy
Secondary	Infant growth