TY - JOUR
T1 - The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART
T2 - A randomized double blind placebo-controlled trial in Uganda
AU - Guwatudde, David
AU - Wang, Molin
AU - Ezeamama, Amara E.
AU - Bagenda, Danstan
AU - Kyeyune, Rachel
AU - Wamani, Henry
AU - Manabe, Yukari C.
AU - Fawzi, Wafaie W.
N1 - Funding Information:
Research findings reported in this article were supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health [grant number R01HD060333]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We acknowledge the trial staff including: Irene Nakatudde, Joanita Murungi, Paul Gonza, Rita Kisenyi, Aidah Zawedde, Eva Laker and Esther Lubwama. We also acknowledge the input by Barbara Castelnuovo, Fred Wabwire-Mangen, Donna Spiegelman and Emily Rose Smith. We are grateful to the trial participants, the support by all IDI staff; and the trial DSMB members Drs. David Schoenfield, Donald Thea, Tom Lutalo and Hanifa Bachou.
Publisher Copyright:
© 2015 Guwatudde et al.
PY - 2015/8/19
Y1 - 2015/8/19
N2 - 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.
AB - 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.
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U2 - 10.1186/s12879-015-1082-x
DO - 10.1186/s12879-015-1082-x
M3 - Article
C2 - 26285704
AN - SCOPUS:84939492457
SN - 1471-2334
VL - 15
JO - BMC infectious diseases
JF - BMC infectious diseases
IS - 1
M1 - 348
ER -