NCT00122941

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Jun 2005

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

Enrollment Period

2.9 years

First QC Date

July 21, 2005

Last Update Submit

June 13, 2008

Conditions

HIV Infections

Keywords

multiplemicronutrientssupplementationHIVchildrenrandomisedtrialmortalitymorbiditygrowthUganda

Outcome Measures

Primary Outcomes (2)

  • Number of children dying during the study period

  • Average weight gain in each of the treatment groups

Secondary Outcomes (5)

  • 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

Interventions

multiple micronutrientsDIETARY_SUPPLEMENT

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for International Health University of Bergen

Bergen, Bergen, NO-5021, Norway

Location

Department of Paediatrics and Child Health, Mulago Hospital

Kampala, Kampala, P.O. 7072, Uganda

Location

Related Publications (10)

  • 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.

    PMID: 14600517BACKGROUND

  • 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.

    PMID: 10197378BACKGROUND

  • 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.

    PMID: 10586170BACKGROUND

  • 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.

    PMID: 10225235BACKGROUND

  • 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.

    PMID: 9108943BACKGROUND

  • 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.

    PMID: 9764785BACKGROUND

  • 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.

    PMID: 15795466BACKGROUND

  • 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.

    PMID: 21600005DERIVED

  • 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.

    PMID: 20858275DERIVED

  • 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.

    PMID: 20525230DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Grace Ndeezi, MMed

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 22, 2005

Study Start

June 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations

NO(1)UG(1)