Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial
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Date
2012
Journal Title
Journal ISSN
Volume Title
Publisher
BMC Infectious Diseases
Abstract
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.
Description
Keywords
HIV infected adults, HAART, Micronutrient supplementation, Nutrition, Randomized double-blind placebocontrolled trial, Trial protocol, Uganda, Sub-Saharan Africa
Citation
Guwatudde et al.: Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial. BMC Infectious Diseases 2012 12:304 doi:10.1186/1471-2334-12-304