In this research study we want to find out if children given vitamins and minerals can be protected from diarrhea caused by germs. We are investigating which vitamins and minerals can improve a child’s weight and growth. We also want to find out if the same thing happens in children who do or do not have HIV, the virus that causes AIDS. A total of 516 children will participate in this research study.

In this research study we will compare three types of mixtures of vitamins and minerals to find out which works better. One of the mixtures will have vitamin A alone. Vitamin A is used internationally in trying to improve the health of children. The government of South Africa has recommended that it be used in children. The second mixture will include vitamin A and zinc. Zinc has been shown to improve the health of children in Asia. We do not know if it will work in children in Africa. The third mixture will include vitamin A, zinc and other vitamins and minerals including vitamins C, D, E, K, B1, B2, B6, B12, iron, niacin, folate, iodine and copper.

Condition	Intervention
Diarrhea	Drug: micronutrient tablets

Further Study Details: 

Primary Outcomes: Prevalent days of diarrhoea 6-24 months
Secondary Outcomes: Pathogens-specific pattern of enteric infections; Cost-effectiveness of micronutrient supplementation; Growth 6-24 months; Persistent diarrhoea 6-24 months
Expected Total Enrollment:  516

THE EFFECT OF PROPHYLACTIC MICRONUTRIENT SUPPLEMENTATION ON MORBIDITY AND GROWTH IN HIV-INFECTED AND HIV-UNINFECTED CHILDREN IN SOUTH AFRICA

COUNTRY: SOUTH AFRICA

ESTIMATED COMPLETION DATE: JUNE 2005

DESIGN: RANDOMIZED, DOUBLE BLIND, CLINICAL CONTROLLED TRIAL

SAMPLE SIZE: 516 children

POPULATION: HIV-infected children; HIV-uninfected children of HIV-infected mothers and HIV-uninfected children of HIV-uninfected mothers from the Mpukunyoni area of Hlabisa District, KwaZulu Natal, South Africa

STRATIFICATION:

1. HIV-infected children n= 156
2. HIV-uninfected children of HIV-infected mothers n=180
3. HIV-uninfected children of HIV-uninfected mothers n=180

REGIMEN:

1. Vitamin A
2. Vitamin A + zinc
3. Multiple micronutrients including vitamin A + zinc

Prophylactic regimen from 6 months until 24 months of age

OBJECTIVES:

Primary objective

To compare the effect of three micronutrient supplements;

1. vitamin A only;
2. vitamin A and zinc;
3. 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 three groups of children;

1. HIV-infected children
2. HIV-uninfected children born to HIV-infected women;
3. HIV-uninfected children born to women without HIV infection

Secondary objectives

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
2. to conduct a cost-effectiveness analysis of micronutrient supplementation in children aged 6-24 months

Tertiary objectives

1. to assess whether either zinc alone or a micronutrient mixture containing zinc affects linear growth and body composition
2. to determine if infection with specific enteric pathogens is associated with the development of persistent diarrhoea lasting >14 days.

MULTIPLE MICRONUTRIENT SUPPLEMENTATION Vitamin A 375 mcg RE (1250 IU) Vitamin D 5 mcg Vitamin E 6 mg a-Toc. Equ. Vitamin K 10 mcg Vitamin C 35 mg Vitamin B1 0.5 mg Vitamin B2 0.5 mg Vitamin B6 0.5 mg Vitamin B12 0.9 mcg Niacin 6 mg Folate 150 mcg Fe 10 mg Zn 10 mg Cu 0.6 mg Iodine 50 mcg

Ages Eligible for Study:  5 Months   -   6 Months,  Genders Eligible for Study:  Both

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, Kwazulu-Natal
      Africa Centre for Health and Population Studies, Durban,  Kwazulu-Natal,  3935,  South Africa
      Africa Centre for Health and Population Studies, Durban,  Kwazulu-Natal,  3935,  South Africa

Study chairs or principal investigators

MICHAEL L BENNISH, MD,  Principal Investigator,  DIRECTOR - AFRICA CENTRE   
JAN ME VAN DEN BROECK, MD PhD,  Study Chair,  CLINICAL TRIALS EPIDEMIOLOGIST - AFRICA CENTRE   

Study ID Numbers:  DMID Protocol 00-095; Grant no: 5 U01 AI058371-05
Last Updated:  September 10, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00156832
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13