Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Micronutrient deficiencies are common in HIV infected children and are aggravated by poor
      nutrition, especially in poor resource countries such as Uganda. It appears that
      micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV
      disease progression. Hitherto, there has been no randomised controlled trial to assess the
      effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected
      children in Africa. Therefore, the investigators shall carry out a randomised controlled
      trial to determine the effect of multiple micronutrient supplementation on morbidity, weight
      gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

      Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of
      multiple micronutrients to HIV infected children aged one to five years, for 6 months, will
      reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain
      difference of 150 grams.
    

Detailed description: 
      Micronutrient deficiencies are common in HIV infected children and are aggravated by poor
      nutrition, especially in poor resource countries such as Uganda. It appears that
      micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV
      disease progression. Hitherto, there has been no randomised controlled trial to assess the
      effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected
      children in Africa. Therefore, the investigators shall carry out a randomised controlled
      trial to determine the effect of multiple micronutrient supplementation on morbidity, weight
      gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

      Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of
      multiple micronutrients to HIV infected children aged one to five years, for 6 months, will
      reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain
      difference of 150 grams.

      A sample size of 373 was calculated assuming that the mortality risk in one year in HIV
      infected children is 24% (Barhane et al) and that this risk will be reduced to 14.4% in the
      intervention group (40% effect size) with 90% power and 95% confidence.

      Assuming a 10% attrition rate (38 study participants), the final sample size in each group is
      411.
    

Intervention name(s): multiple micronutrients
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: multiple; micronutrients; supplementation; HIV; children; randomised; trial; mortality; morbidity; growth; Uganda