Antenatal Micronutrient Supplementation and Birth Weight

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Active, not recruiting
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: April 6, 2012
Last verified: April 2012

June 21, 2005
April 6, 2012
January 1999
Not Provided
  • Birth weight
  • 3-month infant mortality
Same as current
Complete list of historical versions of study NCT00115271 on ClinicalTrials.gov Archive Site
  • Infant morbidity
  • Maternal morbidity
  • Maternal nutritional status
  • Weight gain during pregnancy
  • Infant growth
Same as current
Not Provided
Not Provided
 
Antenatal Micronutrient Supplementation and Birth Weight
Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Low Birth Weight
  • Infant Mortality
  • Pregnancy
  • Nutritional Status
Drug: Nutritional supplements
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
May 2001
Not Provided

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
Female
15 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00115271
H.22.98.09.02.C1
Not Provided
Parul Christian, Johns Hopkins Bloomberg School of Public Health
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
Johns Hopkins Bloomberg School of Public Health
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP