MedTrace Logo

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

NCT00122941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2008-06-16

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DIETARY_SUPPLEMENT

multiple micronutrients

Sponsors & Collaborators

  • The Norwegian Programme for Development, Research and Higher Education

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Grace Ndeezi, MMed · Makerere University, Medical School, Department of Paediatrics and Child Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Norway
  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00122941 on ClinicalTrials.gov