Background: 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 B-complex, 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-to-event 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. Trial registration: Clinical trials NCT01228578 , registered on 15th October 2010.
ASJC Scopus subject areas
- Infectious Diseases