The effect of standard dose multivitamin supplementation on disease progression in HIV infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda
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Date
2015
Journal Title
Journal ISSN
Volume Title
Publisher
BMC infectious diseases
Abstract
Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on
Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double
blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV
supplementation on disease progression in patients initiating HAART.
Methods: Eligible subjects were randomized to receive placebo or MV supplementation including vitamins Bcomplex,
C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell
count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV
disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy
(ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models
were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-toevent
analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality.
Results: Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the
average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a
mean difference of −6 · 17 [95 % CI −29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg
compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI −0 · 40, 1 · 48]; whereas average
change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of −2.16
[95 % CI −4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of
adverse events between the trial arms.
Conclusions: One RDA of MV supplementation was safe but did not have an effect on indicators of disease
progression among HIV infected adults initiating HAART.
Description
Keywords
Dose multivitamin supplementation, Disease progression, HIV infected adults, HAART, Blind placebo-controlled trial, Uganda
Citation
Guwatudde, D., Wang, M., Ezeamama, A. E., Bagenda, D., Kyeyune, R., Wamani, H., ... & Fawzi, W. W. (2015). The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda. BMC infectious diseases, 15(1), 1-10. DOI 10.1186/s12879-015-1082-x