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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00122941
• Date of registration: 21/07/2005
• Primary sponsor: Makerere University
• Public title: Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda MMS
• Scientific title: Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda: a Randomised Double Blind Placebo-Controlled Trial
• Date of first enrolment: June 2005
• Target sample size: 860
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00122941
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Norway, Uganda

Contacts

• Name: Grace Ndeezi, MMed
• Affiliation: Makerere University, Medical School, Department of Paediatrics and Child Health

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: 5 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Dietary Supplement: multiple micronutrients

Primary Outcome(s)

Average weight gain in each of the treatment groups

Number of children dying during the study period

Secondary Outcome(s)

Adverse events related to supplementation

Blood micronutrient levels

HIV disease progression (CD4 count and clinical staging)

Incidence/prevalence of diarrhoea

Prevalence of C. parvum and E. bieneusi

Secondary ID(s)

2002/HD11/2078/MMS

MV910

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Norwegian Programme for Development, Research and Higher Education