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Completed

NCT Number: NCT00109551

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

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.

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Key information

Conditions

Nutrition

Age range

1 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nepal Nutrition Intervention Project-Sarlahi, Kathmandu and Sarlahi District, Nepal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc sulphate dietary supplement

Drug

iron sulphate-folic acid dietary supplement

Drug

Primary outcomes

  1. Death among children 1-36 months of age

Secondary outcomes

  1. Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • Bill and Melinda Gates Foundation
  • United States Agency for International Development (USAID)

Registry information

Official study title

Zinc Supplementation Impact on Child Mortality--Nepal

Important dates

Study start
2001
Study completion
2006
First posted
Apr 29, 2005
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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