Micronutrients and Enteric Infections in African Children
Condition: Enteric Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Vitamin + Zinc + micronutrient mixture; Vitamin A; Vitamin A + Zinc
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Vitamins; Vitamin A; Zinc; Trace Elements; Micronutrients; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: micronutrient, supplementation, Africa, children, HIV