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

Phase 3
Completed
Conditions
Nutrition
Registration Number
NCT00109551
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58000
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Death among children 1-36 months of age
Secondary Outcome Measures
NameTimeMethod
Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections

Trial Locations

Locations (3)

Johns Hopkins Bloomberg School of Public Health

🇺🇸

Baltimore, Maryland, United States

Cornell University Division of Nutritional Sciences

🇺🇸

Ithaca, New York, United States

Nepal Nutrition Intervention Project-Sarlahi

🇳🇵

Kathmandu and Sarlahi District, Nepal

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