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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00109551
First Posted: April 29, 2005
Last Update Posted: May 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)
  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
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Zinc Supplementation Impact on Child Mortality--Nepal

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Death among children 1-36 months of age

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109551


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
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: James M Tielsch, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00109551     History of Changes
Other Study ID Numbers: R01HD038753 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2005
First Posted: April 29, 2005
Last Update Posted: May 1, 2013
Last Verified: January 2006

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:
Zinc
Folic Acid
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex
Vitamins
Astringents
Dermatologic Agents