Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Nov 15:12:304.
doi: 10.1186/1471-2334-12-304.

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial

David Guwatudde  1 , Amara E Ezeamama, Danstan Bagenda, Rachel Kyeyune, Fred Wabwire-Mangen, Henry Wamani, Ferdinand Mugusi, Donna Spiegelman, Molin Wang, Yukari C Manabe, Wafaie W Fawzi
Affiliations
Randomized Controlled Trial

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial

David Guwatudde et al. BMC Infect Dis. .

Abstract

Background: Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda.

Methods/design: We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea.

Discussions: The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting.

Trial registration: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial Schema.
See this image and copyright information in PMC

References

    1. Coyne-Meyers K, Trombley LE. A review of nutrition in human immunodeficiency virus infection in the era of highly active antiretroviral therapy. Nutr Clin Pract. 2004;19(4):340–355. doi: 10.1177/0115426504019004340. - DOI - PubMed
    1. Beisel WR. Single nutrients and immunity. Am J Clin Nutr. 1982;35(2 Suppl):417–468. - PubMed
    1. Dreizen S. Nutrition and the immune response – a review. Int J Vitam Nutr Res. 1979;49(2):220–228. - PubMed
    1. Jiamton S. et al.A randomized trial of the impact of multiple micronutrient supplementation on mortality among HIV-infected individuals living in Bangkok. AIDS. 2003;17(17):2461–2469. doi: 10.1097/00002030-200311210-00008. - DOI - PubMed
    1. Fawzi WW. et al.Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998;351(9114):1477–1482. doi: 10.1016/S0140-6736(98)04197-X. - DOI - PubMed

Publication types

Associated data