Micronutrients and Enteric Infections in African Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00133419
First received: August 19, 2005
Last updated: August 26, 2010
Last verified: March 2007

August 19, 2005
August 26, 2010
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Complete list of historical versions of study NCT00133419 on ClinicalTrials.gov Archive Site
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Micronutrients and Enteric Infections in African Children
The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa

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.

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. The primary objective of this study is to compare the effect of 3 micronutrient supplements (vitamin A only, vitamin A and zinc, and a micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc) on prevalent days of diarrhea in 3 groups of children (HIV-infected children, HIV-uninfected children born to HIV-infected women, and HIV-uninfected children born to women without HIV infection). The secondary objectives of the study are: (1) to describe the pathogen-specific pattern of enteric infections in both HIV-infected and uninfected children during ages 6-24 months, with a focus on infection with C. parvum and other protozoan pathogens and (2) to conduct a cost-effectiveness analysis of micronutrient supplementation in children aged 6-24 months. The tertiary objectives of the study are: (1) to assess whether either zinc alone or a micronutrient mixture containing zinc affects linear growth and body composition and (2) to determine if infection with specific enteric pathogens is associated with the development of persistent diarrhea lasting > 14 days. The proposed study will be conducted through the African Centre for Health and Population Studies located in Hlabisa Health District, in northern KwaZulu Natal (KZN), South Africa. The study is a randomized, double blind, clinical controlled trial with 3 arms in a study population of infants stratified by HIV status and the HIV status of their mothers. Study participants will include a total of 516 infants aged 4-6 months. The following evaluations will be made throughout the study: (1) blood samples, (2) stool sampling-routine (collected at 6, 12, 18, and 24 months of age), (3) stool sampling-during diarrheal episodes, and (3) lean body mass and anthropometry (assessed at 6, 12, 18, and 24 months of age). Study participants will be involved in study related procedures for up to 18 months.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Enteric Infections
  • Drug: Vitamin + Zinc + micronutrient mixture
  • Drug: Vitamin A
  • Drug: Vitamin A + Zinc
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
January 2006
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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

Both
4 Months to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00133419
00-095
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP