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

Sponsor

Makerere University (Other)

Overall Status

Completed

CT.gov ID

NCT00122941

Collaborator

The Norwegian Programme for Development, Research and Higher Education (Other)

860

Enrollment

Locations

Duration (Months)

430

Patients Per Site

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Dietary Supplement: multiple micronutrients	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

860 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

Number of children dying during the study period []
Average weight gain in each of the treatment groups []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for International Health University of Bergen	Bergen		Norway	NO-5021
2	Department of Paediatrics and Child Health, Mulago Hospital	Kampala		Uganda	P.O. 7072