A Randomized Clinical Trial
Marianna K. Baum, PhD1; Adriana Campa, PhD1; Shenghan Lai, MD, MPH5; Sabrina Sales Martinez, MS1; Lesedi Tsalaile, MS2; Patricia Burns, MS, MPH3; Mansour Farahani, MD, PhD3; Yinghui Li, MS1; Erik van Widenfelt, BSc2; John Bryan Page, PhD4; Hermann Bussmann, MD2; Wafaie W. Fawzi, MBBS, DrPH3; Sikhulele Moyo, MPH2; Joseph Makhema, MB, ChB, MRCP2; Ibou Thior, MD2; Myron Essex, DVM, PhD3; Richard Marlink, MD3
1Florida International University, R. Stempel College of Public Health and Social Work, Miami
2Botswana Harvard Partnership, Gaborone, Botswana
3Harvard School of Public Health, Boston, Massachusetts
4University of Miami, Miami, Florida
5Johns Hopkins University School of Medicine, Baltimore, Maryland
Micronutrient deficiencies occur early in human immunodeficiency virus (HIV) infection, and supplementation with micronutrients may be beneficial; however, its effectiveness has not been investigated early in HIV disease among adults who are antiretroviral therapy (ART) naive.
To investigate whether long-term micronutrient supplementation is effective and safe in delaying disease progression when implemented early in adults infected with HIV subtype C who are ART-naive.
Design, Setting, and Participants
Randomized clinical trial of supplementation with either daily multivitamins (B vitamins and vitamins C and E), selenium alone, or multivitamins with selenium vs placebo in a factorial design for 24 months. The study was conducted in 878 patients infected with HIV subtype C with a CD4 cell count greater than 350/μL who were not receiving ART at Princess Marina Hospital in Gaborone, Botswana, between December 2004 and July 2009.
Daily oral supplements of B vitamins and vitamins C and E, selenium alone, or multivitamins plus selenium, compared with placebo.
Main Outcomes and Measures
Reaching a CD4 cell count less than 200/μL until May 2008; after this date, reaching a CD4 cell count of 250/μL or less, consistent with the standard of care in Botswana for initiation of ART at the time of the study.