Micronutrients and Enteric Infections in African Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133419
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Condition or disease Intervention/treatment Phase
Enteric Infections Drug: Vitamin + Zinc + micronutrient mixture Drug: Vitamin A Drug: Vitamin A + Zinc Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133419

South Africa
Africa Centre for Health and Population Studies
Mtubatuba, South Africa, 3935
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00133419     History of Changes
Obsolete Identifiers: NCT00156832
Other Study ID Numbers: 00-095
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: March 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
micronutrient, supplementation, Africa, children, HIV

Additional relevant MeSH terms:
Vitamin A
Trace Elements
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents