One of the largest dialysis studies in history is underway
The nutritional study sponsored by Dialysis Clinic, Inc., has over 5,300 patients enrolled
Nashville, Tenn. (Jan. 24)—Dialysis Clinic, Inc. (DCI) announced today that it is sponsoring one of the largest randomized trials to be conducted in dialysis.
The Health Effects of Oral Protein Supplements in Hemodialysis Patients (HELPS-HD) study will explore the effectiveness of two approaches to the use of oral nutritional supplements. The three-year study has 105 DCI clinics participating with over 5,300 patients enrolled and more are expected to enroll in the coming months.
“This study will help us better understand how to use nutritional supplements to improve the health of dialysis patients,” said Daniel Weiner, MD, HELPS-HD study leader. “Adequate nutrition plays an important role in the overall health of someone suffering from kidney failure. Many dialysis patients lose protein during dialysis, putting stress on their bodies. We want to explore how patients benefit from receiving nutritional supplements during treatment, with the eventual goal that this could be a meaningful and practical intervention to improve the lives of dialysis patients.”
The study divides participants into two groups: in one set of clinics, patients receive protein supplements regardless of their albumin levels while, in the other set of clinics, patients receive supplements based on having a low albumin level in the blood.
“It’s exciting to be able to lead this trial,” said Karen Majchrzak, MS, CCRP, DCI Director of Clinical Research. “Research, which is a large part of DCI’s non-profit mission, allows us to ask questions and find different ways to improve the delivery of kidney care. The dedication of all of the DCI clinics that are participating in the trial is remarkable and speaks to the broad support across DCI for learning more about how to improve care for our patients.”
In 2007, DCI’s Office of Clinical Research was established to review all studies to be conducted in DCI patients to ensure the research is scientifically rigorous, valid, and that the appropriate procedures for human protections are being followed. Previously DCI had conducted the largest study of its kind examining the effect of nutritional vitamin D on anemia management1.
- Miskulin DC, Majchrzak K, Tighiouart H, Muther RS, Kapoian T, Johnson DS, Weiner DE. Ergocalciferol Supplementation in Hemodialysis Patients with Vitamin D Deficiency: A Randomized Clinical Trial, J Am Soc Nephrol. 2016; 6:1801-1810.