Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Zinc Supplementation Impact on Child Mortality--Nepal |
- Death among children 1-36 months of age
- Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections
| 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:
- All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.
Exclusion Criteria:
- Parent refusal
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
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00109551 History of Changes |
| Other Study ID Numbers: | R01 HD38753, R01-HD38753 |
| Study First Received: | April 28, 2005 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government Nepal: Nepal Health Research Council |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
zinc child mortality child morbidity |
community trial prevention trial dietary supplement |
Additional relevant MeSH terms:
|
Folic Acid Vitamin B Complex Zinc Zinc Sulfate Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Trace Elements Astringents Dermatologic Agents |
ClinicalTrials.gov processed this record on June 17, 2013