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

David Guwatudde, Molin Wang, Amara E. Ezeamama, Danstan S Bagenda, Rachel Kyeyune, Henry Wamani, Yukari C. Manabe, Wafaie W. Fawzi

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish (US)
Article number348
JournalBMC Infectious Diseases
Volume15
Issue number1
DOIs
StatePublished - Aug 19 2015

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Uganda
Highly Active Antiretroviral Therapy
Disease Progression
Placebos
HIV
Recommended Dietary Allowances
CD4 Lymphocyte Count
Quality of Life
Weights and Measures
Vitamin B Complex
Mortality
Linear Models
Clinical Trials

ASJC Scopus subject areas

  • Infectious Diseases

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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. / Guwatudde, David; Wang, Molin; Ezeamama, Amara E.; Bagenda, Danstan S; Kyeyune, Rachel; Wamani, Henry; Manabe, Yukari C.; Fawzi, Wafaie W.

In: BMC Infectious Diseases, Vol. 15, No. 1, 348, 19.08.2015.

Research output: Contribution to journalArticle

Guwatudde, David ; Wang, Molin ; Ezeamama, Amara E. ; Bagenda, Danstan S ; Kyeyune, Rachel ; Wamani, Henry ; Manabe, Yukari C. ; Fawzi, Wafaie W. / 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. In: BMC Infectious Diseases. 2015 ; Vol. 15, No. 1.
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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.",
author = "David Guwatudde and Molin Wang and Ezeamama, {Amara E.} and Bagenda, {Danstan S} and Rachel Kyeyune and Henry Wamani and Manabe, {Yukari C.} and Fawzi, {Wafaie W.}",
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T2 - A randomized double blind placebo-controlled trial in Uganda

AU - Guwatudde, David

AU - Wang, Molin

AU - Ezeamama, Amara E.

AU - Bagenda, Danstan S

AU - Kyeyune, Rachel

AU - Wamani, Henry

AU - Manabe, Yukari C.

AU - Fawzi, Wafaie W.

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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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