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Antenatal Micronutrient Supplementation and Birth Weight

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ClinicalTrials.gov Identifier: NCT00115271
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : August 26, 2014
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 5000 participants
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 : January 1999
Primary Completion Date : May 2001
Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205
More Information

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.
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Parul Christian, Johns Hopkins Bloomberg School of Public Health:
Birth weight
Infant mortality

Additional relevant MeSH terms:
Body Weight
Birth Weight
Infant Death
Signs and Symptoms
Pathologic Processes
Trace Elements
Growth Substances
Physiological Effects of Drugs