Multi-vitamins, HAART and HIV/AIDS in Uganda

This study has been completed.
Sponsor:
Collaborators:
Makerere University
Infectious Disease Institute, Kampala, Uganda
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01228578
First received: October 15, 2010
Last updated: May 20, 2014
Last verified: May 2014

October 15, 2010
May 20, 2014
April 2010
November 2013   (final data collection date for primary outcome measure)
  • Weight Gain [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Immune Reconstitution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Immune Reconstitution is measured by change in CD4 cell count
  • Improved Quality of Life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228578 on ClinicalTrials.gov Archive Site
  • New or recurrent disease progression event [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multi-vitamins, HAART and HIV/AIDS in Uganda
Multi-vitamins, HAART and HIV/AIDS in Uganda

The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea).

The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.

Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive populations. Multivitamin supplements have immune-enhancing effects, and supplements were found to improve immunologic status and reduce morbidity and mortality among HIV-positive Tanzanian women in pre-highly active anti-retroviral therapy (HAART) stages of disease. These supplements are thought to be required to restore adequate nutrient levels in the context of HIV infection.

This study will enroll 400 men and women in the Kampala district of Uganda, who are receiving or have recently initiated HAART. At baseline and monthly thereafter, research physicians and nurses at study clinics will assess each participant's clinical status and undertake study procedures. Each participant will be followed for 18 months, or until his/her death or loss to follow-up. Home visits will be conducted if participants miss their scheduled clinic appointments. We will perform nutritional assessments (anthropometry and dietary intake) at enrollment and several follow-up points, and laboratory measurements (CD4 cell counts and complete blood counts) every six months.

Importantly, all study participants will continue receiving the standard of care according to national guidelines for the entire study period. Multivitamins could be a low-cost, adjunct therapy for helping to alleviate disease burden and elevate quality of life in HIV-infected individuals on HAART. At the same time, their efficacy could help preserve limited drug regimens in developing settings by postponing the need for switches to second line regimens of HAART.

Our proposal represents a collaboration between the Harvard School of Public Health, Infectious Disease Institute and Makerere University School of Public Health in Kampala, Uganda.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV/AIDS
Dietary Supplement: Multivitamin supplements B,C and E
One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months
  • Experimental: Multivitamins (B,C,E)
    Intervention: Dietary Supplement: Multivitamin supplements B,C and E
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Multivitamin supplements B,C and E
Guwatudde D, Ezeamama AE, Bagenda D, Kyeyune R, Wabwire-Mangen F, Wamani H, Mugusi F, Spiegelman D, Wang M, Manabe YC, Fawzi WW. Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial. BMC Infect Dis. 2012 Nov 15;12:304. doi: 10.1186/1471-2334-12-304.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men or women aged >=18 years old
  • HIV-positive
  • initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
  • have no intention of migrating, or re-locating >= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
  • agree to allow home visit(s) and subsequent follow-up contacts as part of the study
  • provide written informed consent

Exclusion Criteria:

  • pregnant Women
  • individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01228578
HD060333-01
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
  • Makerere University
  • Infectious Disease Institute, Kampala, Uganda
Principal Investigator: Wafaie W Fawzi, MD,MPH,DrPH Harvard School of Public Health
Principal Investigator: David Guwatudde, MPH, PhD Makerere University School of Public Health
Harvard School of Public Health
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP