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

This study has been completed.

First Received: April 28, 2005 Last Updated: November 2, 2006 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Zinc Supplementation Impact on Child Mortality--Nepal

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Folic acid Zinc sulfate

U.S. FDA Resources

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

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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:

Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Shresta S, Black RE. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):144-52.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Black R, Shresta S. Effect of daily zinc supplementation on child mortality in southern Nepal: a community-based, cluster randomised, placebo-controlled trial. Lancet. 2007 Oct 6;370(9594):1230-9.

Study ID Numbers:	R01 HD38753, R01-HD38753
Study First Received:	April 28, 2005
Last Updated:	November 2, 2006
ClinicalTrials.gov Identifier:	NCT00109551 History of Changes
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:

Vitamin B Complex
Hematinics
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Trace Elements
Pharmacologic Actions
Folic Acid

Zinc Sulfate
Vitamins
Therapeutic Uses
Zinc
Astringents
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010