AzTrials
AzTrials

HIV InfectionsPhase 3MMSNCT00122941

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

A Phase 3 study testing multiple micronutrients in people with HIV Infections, run by Makerere University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 5 years
Conditions the study is for
HIV Infections
What is being tested?
multiple micronutrients
How many people
860 participants
Where
2 sitesin 2 countries
Study dates
Jun 2005to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site

  • Centre for International Health University of Bergen

    Bergen, Bergen, NO-5021

Other trials in Norway

Uganda1 site

  • Department of Paediatrics and Child Health, Mulago Hospital

    Kampala, Kampala, P.O. 7072

Other trials in Uganda

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
multiple micronutrients
Keywords
multiple, micronutrients, supplementation, HIV, children, randomised, trial, mortality, morbidity, growth, Uganda
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multiple micronutrientsDietary supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of children dying during the study period

  2. Average weight gain in each of the treatment groups

Secondary outcomes (5)

  1. Blood micronutrient levels

  2. Incidence/prevalence of diarrhoea

  3. HIV disease progression (CD4 count and clinical staging)

  4. Prevalence of C. parvum and E. bieneusi

  5. Adverse events related to supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
860 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122941
Sponsor's protocol ID
2002/HD11/2078/MMS
Other IDs
MV910
Acronym
MMS
Status last verified
Jun 2008
First submitted
21 Jul 2005
Last updated
16 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14600517

  • 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.

    PubMed 10197378

  • 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.

    PubMed 10586170

  • 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.

    PubMed 10225235

  • 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.

    PubMed 9108943

  • 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.

    PubMed 9764785

  • 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.

    PubMed 15795466

  • 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.

    PubMed 21600005

  • 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.

    PubMed 20858275

  • 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.

    PubMed 20525230

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing multiple micronutrients in people with HIV Infections, run by Makerere University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of children dying during the study period. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122941, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2008.

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