drugset / Trial / NCT00133419

Micronutrients and Enteric Infections in African Children

NCT00133419

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.

Timeline

Start
Primary completion
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin A Unknown 1250 iu
Subject Zinc Sulfate Unknown 10 mg
Subject micronutrient mixture Unknown