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

Tracking Information

First Received Date ^ICMJE

April 28, 2005

Last Updated Date

November 2, 2006

Start Date ^ICMJE

October 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Death among children 1-36 months of age

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00109551 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Zinc Supplementation Impact on Child Mortality--Nepal

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Nutrition

Intervention ^ICMJE

Drug: zinc sulphate dietary supplement
Drug: iron sulphate-folic acid dietary supplement

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

58000

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 36 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Nepal

Administrative Information

NCT ID ^ICMJE

NCT00109551

Responsible Party

Study ID Numbers ^ICMJE

R01 HD38753, R01-HD38753

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Investigators ^ICMJE

Principal Investigator:

James M Tielsch, PhD

Johns Hopkins Bloomberg School of Public Health

Information Provided By

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

Verification Date

January 2006

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