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	Treatment or Intervention	Phase
Nutrition	Drug: zinc sulphate dietary supplement  Drug: iron sulphate-folic acid dietary supplement	Phase III

Further Study Details: 

Primary Outcomes: Death among children 1-36 months of age
Secondary Outcomes: Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections
Expected Total Enrollment:  58000

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.

Ages Eligible for Study:  1 Month   -   36 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109551

James M Tielsch, PhD      410 955-2436    jtielsch@jhsph.edu

Maryland
      Johns Hopkins Bloomberg School of Public Health, Baltimore,  Maryland,  21205-2103,  United States; Completed
New York
      Cornell University Division of Nutritional Sciences, Ithaca,  New York,  14853,  United States; Completed
Nepal
      Nepal Nutrition Intervention Project-Sarlahi, Kathmandu and Sarlahi District,  Nepal; Recruiting

Study chairs or principal investigators

James M Tielsch, PhD,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health   

Study ID Numbers:  R01 HD38753; R01-HD38753
Record last reviewed:  April 2005
Last Updated:  April 29, 2005
Record first received:  April 28, 2005
ClinicalTrials.gov Identifier:  NCT00109551
Health Authority: United States: Federal Government; Nepal: Nepal Health Research Council (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03