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

This study has been completed.
Sponsor:
Collaborator:
The Norwegian Programme for Development, Research and Higher Education
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00122941
First received: July 21, 2005
Last updated: June 13, 2008
Last verified: June 2008

July 21, 2005
June 13, 2008
June 2005
May 2008   (final data collection date for primary outcome measure)
  • Number of children dying during the study period
  • Average weight gain in each of the treatment groups
Same as current
Complete list of historical versions of study NCT00122941 on ClinicalTrials.gov Archive Site
  • 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
  • Blood micronutrient levels
  • Incidence/prevalence of diarrhoea
  • HIV disease progression (CD4 count & clinical staging)
  • Prevalence of C.parvum and E.bieneusi
  • Adverse events related to supplementation
Not Provided
Not Provided
 
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda: a Randomised Double Blind Placebo-Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
Dietary Supplement: multiple micronutrients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
860
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
1 Year to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Uganda
 
NCT00122941
2002/HD11/2078/MMS, MV910
Yes
James K Tumwine, Makerere University Medical School
Makerere University
The Norwegian Programme for Development, Research and Higher Education
Principal Investigator: Grace Ndeezi, MMed Makerere University, Medical School, Department of Paediatrics and Child Health
Makerere University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP