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Micronutrients and Enteric Infections in African Children

NCT00133419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2010-08-27

No results posted yet for this study

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.

Conditions

  • Enteric Infections

Interventions

DRUG

Vitamin + Zinc + micronutrient mixture

DRUG

Vitamin A

DRUG

Vitamin A + Zinc

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Completion
2006-01-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133419 on ClinicalTrials.gov