Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00109551
First received: April 28, 2005
Last updated: April 30, 2013
Last verified: January 2006

April 28, 2005
April 30, 2013
October 2001
Not Provided
Death among children 1-36 months of age
Same as current
Complete list of historical versions of study NCT00109551 on ClinicalTrials.gov Archive Site
Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections
Same as current
Not Provided
Not Provided
 
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
Zinc Supplementation Impact on Child Mortality--Nepal

The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.

Mortality rates among preschool age children in Nepal and many other developing countries remain high despite significant progress made over the past 20 years. There remain significant nutritional deficiencies in these populations, especially important are vitamin and mineral deficiencies.

Comparisons: In this study, we are comparing the morbidity and mortality experience for children 1-36 months of age randomized to one of four daily supplementation regimens: placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Nutrition
  • Drug: zinc sulphate dietary supplement
  • Drug: iron sulphate-folic acid dietary supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58000
January 2006
Not Provided

Inclusion Criteria:

  • All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

  • Parent refusal
Both
1 Month to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Nepal
 
NCT00109551
R01 HD38753, R01-HD38753
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • United States Agency for International Development (USAID)
  • Bill and Melinda Gates Foundation
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2006

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