Micronutrients and Enteric Infections in African Children
Micronutrients and Enteric Infections in African Children
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.
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