Antenatal Micronutrient Supplementation and Birth Weight

Overview

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.

Full Title of Study: “Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double
  • Study Primary Completion Date: May 2001

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

  • Drug: Nutritional supplements

Clinical Trial Outcome Measures

Primary Measures

  • Birth weight
  • 3-month infant mortality

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins Bloomberg School of Public Health
  • Collaborator
    • United States Agency for International Development (USAID)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Parul Christian, Professor – Johns Hopkins Bloomberg School of Public Health
  • Overall Official(s)
    • Parul Christian, DrPH, Principal Investigator, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205

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