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
  Purpose

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.


Condition Intervention Phase
Nutrition
Drug: zinc sulphate dietary supplement
Drug: iron sulphate-folic acid dietary supplement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Zinc Supplementation Impact on Child Mortality--Nepal

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Death among children 1-36 months of age

Secondary Outcome Measures:
  • Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections

Estimated Enrollment: 58000
Study Start Date: October 2001
Estimated Study Completion Date: January 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Month to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109551

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205-2103
United States, New York
Cornell University Division of Nutritional Sciences
Ithaca, New York, United States, 14853
Nepal
Nepal Nutrition Intervention Project-Sarlahi
Kathmandu and Sarlahi District, Nepal
Sponsors and Collaborators
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00109551     History of Changes
Other Study ID Numbers: R01 HD38753, R01-HD38753
Study First Received: April 28, 2005
Last Updated: April 30, 2013
Health Authority: United States: Federal Government
Nepal: Nepal Health Research Council

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
zinc
child mortality
child morbidity
community trial
prevention trial
dietary supplement

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Zinc
Zinc Sulfate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Trace Elements
Astringents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 24, 2014