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.
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.


BACKGROUND
Clinical trials NCT01228578 , registered on 15th October 2010.
School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda. dguwatudde@musph.ac.ug.
David
D
Guwatudde
Departments of Epidemiology and Biostatistics, Harvard School of Public Health, Channing Division of Network Medicine, Harvard Medical School, Boston, MA, USA. stmow@channing.harvard.edu.
Molin
M
Wang
Department of Epidemiology and Biostatistics, University of Georgia, Athens, GA, USA. aezeamam@uga.edu.
Amara E
AE
Ezeamama
School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda. dbagenda@hsph.harvard.edu.|Department of Global Health and Population, Harvard School of Public Health, Boston, MA, USA. dbagenda@hsph.harvard.edu.
Danstan
D
Bagenda
Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda. smilin.rasasa@gmail.com.
Rachel
R
Kyeyune
School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda. hwamani@musph.ac.ug.
Henry
H
Wamani
Division of Infectious Diseases, Department of Medicine, John Hopkins University, Baltimore, MD, USA. ymanabe@jhmi.edu.
Yukari C
YC
Manabe
Departments of Global Health and Population, Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA. mina@hsph.harvard.edu.
Wafaie W
WW
Fawzi
D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001835:Body Weight; D018791:CD4 Lymphocyte Count; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D064167:Recommended Dietary Allowances; D016896:Treatment Outcome; D014454:Uganda; D014815:Vitamins / Q000627:therapeutic use*; D055815:Young Adult
D014815:Vitamins