Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda

Study Overview
=================
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.

Official Title
-----------------
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda: a Randomised Double Blind Placebo-Controlled Trial

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Dietary Supplement: multiple micronutrients


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: multiple micronutrients|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children dying during the study period |  |  | 
| Average weight gain in each of the treatment groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood micronutrient levels |  |  | 
| Incidence/prevalence of diarrhoea |  |  | 
| HIV disease progression (CD4 count and clinical staging) |  |  | 
| Prevalence of C. parvum and E. bieneusi |  |  | 
| Adverse events related to supplementation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple, micronutrients, supplementation, HIV, children, randomised, trial, mortality, morbidity, growth, Uganda