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

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status and phase

Completed
Phase 3

Conditions

Nutrition

Treatments

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

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT00109551
R01HD038753 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 to 36 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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