Antenatal Micronutrient Supplementation and Birth Weight

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00115271
• Collaborator: United States Agency for International Development (USAID) (U.S. Fed), Bill and Melinda Gates Foundation (Other), Johns Hopkins University (Other)
• Enrollment: 5,000
• Duration (Months): 28

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Birth Weight; Infant Mortality; Pregnancy; Nutritional Status	Drug: Nutritional supplements	Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal
• Study Start Date: Jan 1, 1999
• Actual Primary Completion Date: May 1, 2001
• Actual Study Completion Date: May 1, 2001

Outcome Measures

Primary Outcome Measures

1. Birth weight []

2. 3-month infant mortality []

Secondary Outcome Measures

1. Infant morbidity []

2. Maternal morbidity []

3. Maternal nutritional status []

4. Weight gain during pregnancy []

5. Infant growth []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Parul Christian, DrPH, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT00115271
• Other Study ID Numbers: H.22.98.09.02.C1
• First Posted: Jun 22, 2005
• Last Update Posted: Aug 26, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health: Micronutrients; Supplementation; Pregnancy; Birth weight; Infant mortality
• Additional relevant MeSH terms: Body Weight; Birth Weight; Infant Death

Study Results

No Results Posted as of Aug 26, 2014