Micronutrients and enteric enfections in African children (Protocol)

Condition	Intervention	Phase
Enteric Infections	Drug: Vitamin + Zinc + micronutrient mixture  Drug: Vitamin A  Drug: Vitamin A + Zinc	Phase II

Further Study Details: 

Expected Total Enrollment:  516

A major initiative to reduce the impact of enteric infections on health and nutrition has been micronutrient supplementation. Measures for routine vitamin A and zinc supplementation are gaining increasing support from international agencies, including UNICEF and the WHO. Information on the utility of supplementation with these micronutrients, and especially supplementation with zinc, come largely from studies conducted in the Indian sub-continent and other regions of Asia, regions that differ from sub-Saharan Africa in a number of important characteristics. There is little information on the potential utility of micronutrient supplementation on infection and health of African children. Correlation of enteric pathogens, particularly C. parvum genotypes, with epidemiological (drinking water source, contact with domestic animals, etc.), and clinical features (HIV status, CD4 counts, viral load, severity of illness) may provide important information such as source of infection, route of transmission, and susceptibility of HIV-infected children to infection with a particular pathogen. In addition to children with HIV infection, two groups of HIV-uninfected children will also be enrolled in this proposed study - those born to HIV-infected mothers, and those who are born to HIV-uninfected mothers. Uninfected children born to HIV-infected mothers are likely to resemble HIV-infected children in their socioeconomic characteristics. Children of HIV-uninfected mothers are included for two reasons. First, the care practices of mothers who have HIV infection may differ from mothers without HIV. This may alter the infants'''' nutritional status and predispose to enteric and other infections. Secondly, and more significantly, HIV-infected mothers whose children are uninfected at 4 months will be advised to stop breastfeeding completely as soon as possible after the child has reached 6 months of age. In contrast, uninfected mothers will be advised to continue breastfeeding until the child is at least two years old. This difference in feeding practice may have an important effect on the pattern of enteric infections in the first two years of the child''''s life. In any case, despite the very high rate of HIV infection in this community (approximately 35% of all pregnant women), the majority of women are not HIV-infected, and it is important to determine the potential utility of micronutrients in these children.

Ages Eligible for Study:  4 Months   -   6 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials

South Africa
      Africa Centre for Health and Population Studies, Mtubatuba,  3935,  South Africa

Study ID Numbers:  00-095
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133419
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23