Micronutrients and Enteric Infections in African Children

NCT ID: NCT00133419

Last Updated: 2010-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2006-01-31

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.

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.

Conditions

Enteric Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Vitamin + Zinc + micronutrient mixture

Intervention Type: DRUG

Vitamin A

Intervention Type: DRUG

Vitamin A + Zinc

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

Africa Centre for Health and Population Studies

Mtubatuba, , South Africa

Countries

South Africa

References

Chhagan MK, Van den Broeck J, Luabeya KK, Mpontshane N, Tomkins A, Bennish ML. Effect on longitudinal growth and anemia of zinc or multiple micronutrients added to vitamin A: a randomized controlled trial in children aged 6-24 months. BMC Public Health. 2010 Mar 18;10:145. doi: 10.1186/1471-2458-10-145.

Reference Type: DERIVED

PMID: 20298571 (View on PubMed)

Chhagan MK, Van den Broeck J, Luabeya KK, Mpontshane N, Tucker KL, Bennish ML. Effect of micronutrient supplementation on diarrhoeal disease among stunted children in rural South Africa. Eur J Clin Nutr. 2009 Jul;63(7):850-7. doi: 10.1038/ejcn.2008.78. Epub 2009 Jan 28.

Reference Type: DERIVED

PMID: 19174830 (View on PubMed)

Luabeya KK, Mpontshane N, Mackay M, Ward H, Elson I, Chhagan M, Tomkins A, Van den Broeck J, Bennish ML. Zinc or multiple micronutrient supplementation to reduce diarrhea and respiratory disease in South African children: a randomized controlled trial. PLoS One. 2007 Jun 27;2(6):e541. doi: 10.1371/journal.pone.0000541.

Reference Type: DERIVED

PMID: 17593956 (View on PubMed)

Other Identifiers

00-095

Identifier Type: -

Identifier Source: org_study_id

NCT00156832

Identifier Type: -

Identifier Source: nct_alias