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Completed

NCT Number: NCT00115271

Antenatal Micronutrient Supplementation and Birth Weight

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.

Completed

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Key information

Conditions

Low Birth Weight Birth Weight Body Weight Death Infant Death Infant Mortality Nutritional Status Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional supplements

Drug

Primary outcomes

  1. Birth weight

  2. 3-month infant mortality

Secondary outcomes

  1. Infant morbidity

  2. Maternal morbidity

  3. Maternal nutritional status

  4. Weight gain during pregnancy

  5. Infant growth

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Johns Hopkins University
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2001
Study completion
2001
First posted
Jun 22, 2005
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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