Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda (MMS)
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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 |
- Number of children dying during the study period
- Average weight gain in each of the treatment groups
- 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) |
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 |
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| 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 | |
| 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 June 17, 2013