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
  Purpose

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 Intervention Phase
HIV Infections
Dietary Supplement: multiple micronutrients
Phase 3

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
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

Resource links provided by NLM:


Further study details as provided by Makerere University:

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

Enrollment: 860
Study Start Date: June 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122941

Locations
Norway
Centre for International Health University of Bergen
Bergen, Norway, NO-5021
Uganda
Department of Paediatrics and Child Health, Mulago Hospital
Kampala, Uganda, P.O. 7072
Sponsors and Collaborators
Makerere University
The Norwegian Programme for Development, Research and Higher Education
Investigators
Principal Investigator: Grace Ndeezi, MMed Makerere University, Medical School, Department of Paediatrics and Child Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James K Tumwine, Makerere University Medical School
ClinicalTrials.gov Identifier: NCT00122941     History of Changes
Other Study ID Numbers: 2002/HD11/2078/MMS, MV910
Study First Received: July 21, 2005
Last Updated: June 13, 2008
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
multiple
micronutrients
supplementation
HIV
children
randomised
trial
mortality
morbidity
growth
Uganda

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014