Research for treatments, prevention and a cure
DEBUG INFO [ON]
Page template: single-clinical-trials.php
Search terms : 

Clinical Trials

  • Clinical Studies

Clinical Management Science (CMS)


CTN 238: The MAINTAIN study

A randomized control clinical trial of micronutrient and antioxidant supplementation in persons with untreated HIV infection

Print Friendly, PDF & Email

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)

Study Approach

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.

Preliminary Results

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.

Additional Information

If you would like more information on this clinical study, please refer to clinicaltrials.gov.

Principal Investigator

Dr. Bill Cameron,
The Ottawa Hospital
Ph: 613-737-8209

 

Publications:

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.

Latest News

Inaugural Steatohepatitis in HIV Workshop Launched

| Uncategorized | No Comments

The goal of this workshop is to provide a multidisciplinary view of the current state of nonalcoholic steatohepatitis (NASH) in HIV and establish a collaborative platform for related research projects.

Guest Blog: Dr. Kiffer G. Card

| Uncategorized | No Comments

Dr. Card, CTN Postdoctoral Fellow, provides an overview of his fellowship project, using national survey data to shed light on patterns of substance use and how they relate to HIV risk in gbMSM.

This is our community: World AIDS Day 2018

| Uncategorized | No Comments

Bridging the Gap: Community and researchers allied in fight to end HIV There is a line in Tony Kushner’s 1991…

CTN at AIDS 2018

| Uncategorized | No Comments

The 22nd International AIDS Conference (AIDS 2018) is the premier gathering for individuals working in the field of HIV, policy makers,…

Research for treatments, prevention and a cure