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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborators: |
United States Agency for International Development (USAID) Bill and Melinda Gates Foundation |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00109551 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nutrition |
Drug: zinc sulphate dietary supplement Drug: iron sulphate-folic acid dietary supplement |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Zinc Supplementation Impact on Child Mortality--Nepal |
| Estimated Enrollment: | 58000 |
| Study Start Date: | October 2001 |
| Estimated Study Completion Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 1 Month to 36 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Bloomberg School of Public Health | |
| Baltimore, Maryland, United States, 21205-2103 | |
| United States, New York | |
| Cornell University Division of Nutritional Sciences | |
| Ithaca, New York, United States, 14853 | |
| Nepal | |
| Nepal Nutrition Intervention Project-Sarlahi | |
| Kathmandu and Sarlahi District, Nepal | |
| Principal Investigator: | James M Tielsch, PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
| Study ID Numbers: | R01 HD38753, R01-HD38753 |
| Study First Received: | April 28, 2005 |
| Last Updated: | November 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00109551 History of Changes |
| Health Authority: | United States: Federal Government; Nepal: Nepal Health Research Council |
|
zinc child mortality child morbidity |
community trial prevention trial dietary supplement |
|
Vitamin B Complex Hematinics Growth Substances Physiological Effects of Drugs Hematologic Agents Trace Elements Pharmacologic Actions Folic Acid |
Zinc Sulfate Vitamins Therapeutic Uses Zinc Astringents Micronutrients Dermatologic Agents |