Clinical Trials Directory

Trials / Completed

CompletedNCT00623857

Micronutrients and Child Health Study

Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
612 (actual)
Sponsor
Wageningen University · Academic / Other
Sex
All
Age
6 Months – 60 Months
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.

Detailed description

Zinc is essential for the functioning of the immune system. Supplementation trials in Asia, Latin America, the Pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in Africa, where the primary environmental challenge to children's health is malaria. Simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. The project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTZincDaily oral supplementation with zinc, 10 mg, for an average of 60 weeks
DIETARY_SUPPLEMENTVitamins and minerals other than zincDaily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
DIETARY_SUPPLEMENTVitamins plus zinc and other mineralsDaily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks
DIETARY_SUPPLEMENTPlaceboDaily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

Timeline

Start date
2008-03-01
Primary completion
2009-03-01
Completion
2009-03-01
First posted
2008-02-26
Last updated
2014-11-17

Locations

1 site across 1 country: Tanzania

Source: ClinicalTrials.gov record NCT00623857. Inclusion in this directory is not an endorsement.