Multivitamin supplementation in HIV infected adults initiating antiretroviral
therapy in Uganda: the protocol for a randomized double blinded placebo
controlled efficacy trial.
Author(s): Guwatudde D, Ezeamama AE, Bagenda D, Kyeyune R, Wabwire-Mangen F, Wamani H,
Mugusi F, Spiegelman D, Wang M, Manabe YC, Fawzi WW.
Affiliation(s): School of Public Health, Makerere University College of Health Sciences, PO Box
7072, Kampala, Uganda. dguwatudde@musph.ac.ug
Publication date & source: 2012, BMC Infect Dis. , 12:304
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.
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