• Login
    View Item 
    •   Athenaeum Home
    • BioMed Central Open Access Articles
    • Open Access Articles by UGA Faculty
    • View Item
    •   Athenaeum Home
    • BioMed Central Open Access Articles
    • Open Access Articles by UGA Faculty
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    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

    Thumbnail
    View/Open
    12879_2015_Article_1082.pdf (679.7Kb)
    Date
    2015-08-19
    Author
    Guwatudde, David
    Wang, Molin
    Ezeamama, Amara E
    Bagenda, Danstan
    Kyeyune, Rachel
    Wamani, Henry
    Manabe, Yukari C
    Fawzi, Wafaie W
    Metadata
    Show full item record
    Abstract
    Abstract 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.
    URI
    http://dx.doi.org/10.1186/s12879-015-1082-x
    http://hdl.handle.net/10724/32626
    Collections
    • Open Access Articles by UGA Faculty

    About Athenaeum | Contact Us | Send Feedback
     

     

    Browse

    All of AthenaeumCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjects

    My Account

    LoginRegister

    About Athenaeum | Contact Us | Send Feedback