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

NCT ID: NCT00122941

Last Updated: 2008-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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multiple micronutrients supplementation HIV children randomised trial mortality morbidity growth Uganda

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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multiple micronutrients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Norwegian Programme for Development, Research and Higher Education

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Makerere University Medical School

Principal Investigators

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Grace Ndeezi, MMed

Role: PRINCIPAL_INVESTIGATOR

Makerere University, Medical School, Department of Paediatrics and Child Health

Locations

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Centre for International Health University of Bergen

Bergen, Bergen, Norway

Site Status

Department of Paediatrics and Child Health, Mulago Hospital

Kampala, Kampala, Uganda

Site Status

Countries

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Norway Uganda

References

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Jiamton S, Pepin J, Suttent R, Filteau S, Mahakkanukrauh B, Hanshaoworakul W, Chaisilwattana P, Suthipinittharm P, Shetty P, Jaffar S. A randomized trial of the impact of multiple micronutrient supplementation on mortality among HIV-infected individuals living in Bangkok. AIDS. 2003 Nov 21;17(17):2461-9. doi: 10.1097/00002030-200311210-00008.

Reference Type BACKGROUND
PMID: 14600517 (View on PubMed)

Kelly P, Musonda R, Kafwembe E, Kaetano L, Keane E, Farthing M. Micronutrient supplementation in the AIDS diarrhoea-wasting syndrome in Zambia: a randomized controlled trial. AIDS. 1999 Mar 11;13(4):495-500. doi: 10.1097/00002030-199903110-00008.

Reference Type BACKGROUND
PMID: 10197378 (View on PubMed)

Bhutta ZA, Black RE, Brown KH, Gardner JM, Gore S, Hidayat A, Khatun F, Martorell R, Ninh NX, Penny ME, Rosado JL, Roy SK, Ruel M, Sazawal S, Shankar A. Prevention of diarrhea and pneumonia by zinc supplementation in children in developing countries: pooled analysis of randomized controlled trials. Zinc Investigators' Collaborative Group. J Pediatr. 1999 Dec;135(6):689-97. doi: 10.1016/s0022-3476(99)70086-7.

Reference Type BACKGROUND
PMID: 10586170 (View on PubMed)

Campa A, Shor-Posner G, Indacochea F, Zhang G, Lai H, Asthana D, Scott GB, Baum MK. Mortality risk in selenium-deficient HIV-positive children. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Apr 15;20(5):508-13. doi: 10.1097/00042560-199904150-00015.

Reference Type BACKGROUND
PMID: 10225235 (View on PubMed)

Tang AM, Graham NM, Semba RD, Saah AJ. Association between serum vitamin A and E levels and HIV-1 disease progression. AIDS. 1997 Apr;11(5):613-20. doi: 10.1097/00002030-199705000-00009.

Reference Type BACKGROUND
PMID: 9108943 (View on PubMed)

Allard JP, Aghdassi E, Chau J, Tam C, Kovacs CM, Salit IE, Walmsley SL. Effects of vitamin E and C supplementation on oxidative stress and viral load in HIV-infected subjects. AIDS. 1998 Sep 10;12(13):1653-9. doi: 10.1097/00002030-199813000-00013.

Reference Type BACKGROUND
PMID: 9764785 (View on PubMed)

Fawzi W, Msamanga G, Spiegelman D, Hunter DJ. Studies of vitamins and minerals and HIV transmission and disease progression. J Nutr. 2005 Apr;135(4):938-44. doi: 10.1093/jn/135.4.938.

Reference Type BACKGROUND
PMID: 15795466 (View on PubMed)

Ndeezi G, Tumwine JK, Ndugwa CM, Bolann BJ, Tylleskar T. Multiple micronutrient supplementation improves vitamin B(1)(2) and folate concentrations of HIV infected children in Uganda: a randomized controlled trial. Nutr J. 2011 May 21;10:56. doi: 10.1186/1475-2891-10-56.

Reference Type DERIVED
PMID: 21600005 (View on PubMed)

Ndeezi G, Tumwine JK, Bolann BJ, Ndugwa CM, Tylleskar T. Zinc status in HIV infected Ugandan children aged 1-5 years: a cross sectional baseline survey. BMC Pediatr. 2010 Sep 21;10:68. doi: 10.1186/1471-2431-10-68.

Reference Type DERIVED
PMID: 20858275 (View on PubMed)

Ndeezi G, Tylleskar T, Ndugwa CM, Tumwine JK. Effect of multiple micronutrient supplementation on survival of HIV-infected children in Uganda: a randomized, controlled trial. J Int AIDS Soc. 2010 Jun 3;13:18. doi: 10.1186/1758-2652-13-18.

Reference Type DERIVED
PMID: 20525230 (View on PubMed)

Other Identifiers

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MV910

Identifier Type: -

Identifier Source: secondary_id

2002/HD11/2078/MMS

Identifier Type: -

Identifier Source: org_study_id