HIV Infections
Conditions
Keywords
multiple, micronutrients, supplementation, HIV, children, randomised, trial, mortality, morbidity, growth, Uganda
Brief 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.
Interventions
DIETARY_SUPPLEMENTmultiple micronutrients
Sponsors
The Norwegian Programme for Development, Research and Higher Education
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Aged 1 to 5 years * HIV infection (previously confirmed by 2 ELISAs for children \> 18 months; DNA PCR for those \< 18 months) * Informed consent from the parent/caretaker * Ability to return for follow-up (lives within a radius of 15 km from hospital and unlikely to change residence during the course of the study)
Exclusion criteria
* Children already enrolled in other studies * Children with severe abnormalities which are likely to impair oral intake (for example, severe cerebral palsy) * Severely ill children requiring urgent admission and resuscitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of children dying during the study period | — |
| Average weight gain in each of the treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV disease progression (CD4 count and clinical staging) | — |
| Blood micronutrient levels | — |
| Adverse events related to supplementation | — |
| Prevalence of C. parvum and E. bieneusi | — |
| Incidence/prevalence of diarrhoea | — |
Countries
Norway, Uganda
Outcome results
None listed