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

Zinc Supplementation Impact on Child Mortality--Nepal

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109551
Enrollment
58000
Registered
2005-04-29
Start date
2001-10-31
Completion date
2006-01-31
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition

Keywords

zinc, child mortality, child morbidity, community trial, prevention trial, dietary supplement

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.

Interventions

DRUGzinc sulphate dietary supplement
DRUGiron sulphate-folic acid dietary supplement

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
Bill and Melinda Gates Foundation
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Death among children 1-36 months of age

Secondary

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

Countries

Nepal, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026