Enteric Infections Clinical Trial
Official title:
The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Verified date | March 2007 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 516 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Months to 6 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | Africa Centre for Health and Population Studies | Mtubatuba |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
South Africa,
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03313128 -
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
|
||
Completed |
NCT03468114 -
The Safe Start Trial - Kisumu, Kenya
|
N/A |