Trials / Completed
CompletedNCT00109551
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
Zinc Supplementation Impact on Child Mortality--Nepal
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58,000 (planned)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- All
- Age
- 1 Month – 36 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zinc sulphate dietary supplement | |
| DRUG | iron sulphate-folic acid dietary supplement |
Timeline
- Start date
- 2001-10-01
- Completion
- 2006-01-01
- First posted
- 2005-04-29
- Last updated
- 2013-05-01
Locations
3 sites across 2 countries: United States, Nepal
Source: ClinicalTrials.gov record NCT00109551. Inclusion in this directory is not an endorsement.