Antenatal Micronutrient Supplementation and Birth Weight

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Johns Hopkins University
Information provided by (Responsible Party):
Parul Christian, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00115271
First received: June 21, 2005
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Low Birth Weight
Infant Mortality
Pregnancy
Nutritional Status
Drug: Nutritional supplements
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Birth weight
  • 3-month infant mortality

Secondary Outcome Measures:
  • Infant morbidity
  • Maternal morbidity
  • Maternal nutritional status
  • Weight gain during pregnancy
  • Infant growth

Estimated Enrollment: 5000
Study Start Date: January 1999
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00115271

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
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00115271     History of Changes
Other Study ID Numbers: H.22.98.09.02.C1
Study First Received: June 21, 2005
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Micronutrients
Supplementation
Pregnancy
Birth weight
Infant mortality

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014