About the study
This study will examine if supplementation of a specially enhanced micronutrient preparation, compared to standard vitamins, can slow disease progression or delay the start of ARVs in asymptomatic adults currently not needing nor taking ARVs. Researchers will examine the safety and effect of the supplement on participants’ health and well-being over two years. This is a three-year study recruiting 218 participants from The Ottawa Hospital and participating CTN sites.
Participants will be randomly assigned to one of the two following equal groups:
• Group A (experimental arm): Participants will receive an oral micronutrient antioxidant preparation daily (K-PAX Ultra®)
• Group B (control arm): Participants will receive identical appearing standard multivitamins (Centrum-like)
Each group will take 8 capsules twice daily with food. Neither the participant nor the doctor will know which treatment is being administered. Though the role of supplementation remains unclear, some studies show that supplementation of micronutrient antioxidants may help protect an individual’s immunity and health. This is important because even in the early stage of HIV infection, persons commonly experience lower blood levels of micronutrients (vitamins and minerals) which may increase the risk of disease progression to AIDS.
Study researchers measured how well the trial participants were adhering to the treatment regimens using pill counts and two self-reported measurement scales. Treatment adherence was found to be high in the study group, over 80%. Preliminary analysis of micronutrient levels in blood samples showed that micronutrient deficiencies were common in study participants.
Singhal N, Fergusson D, Huff H, Mills EJ, la Porte C, Walmsley SL, Cameron DW. Design and methods of the MAINTAIN study: a randomized controlled clinical trial of micronutrient and antioxidant supplementation in untreated HIV infection. Contemporary clinical trials. 2010 Nov;31(6):604-611.
Balfour L, Spaans JN, Fergusson D, Huff H, Mills EJ, la Porte CJ, Walmsley SL, Singhal N, Rosenes R, Tremblay N, Gill MJ, Loemba H, Conway B, Rachlis A, Ralph E, Loutfy MR, Mallick R, Moorhouse R, Cameron DW. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naïve persons with HIV. PLOS ONE. 2014 Jan;9(1):e85607.