DCI Achieves Patient Randomization Goal in Study
NASHVILLE, TN (October 2, 2013) — An interventional study is being conducted by Dialysis Clinic, Inc. (DCI) to determine the safety and effect of supplementation with ergocalciferol (nutritional vitamin D or D2) on erythropoietin (EPO) dosing in hemodialysis patients.
Karen Majchrzak, Director of Clinical Research at DCI stated, “We are thrilled to have achieved our patient randomization goal of 276 subjects with a low vitamin D level. To our knowledge this will be the largest study of its kind examining the effect of nutritional vitamin D on EPO dosing.”
There are few studies in the literature examining the effects of ergocalciferol or cholecalciferol on erythropoietin stimulating agents (ESA) dosing. These studies, primarily observational, show conflicting results. One study in particular was a prospective clinical trial; however it was a small, single center study lacking a control arm. DCI is conducting a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and to determine effects on EPO dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.
“There is still much to learn about anemia management. Over the years, the focus has been on iron administration and ESAs. We are trying to uncover other factors that contribute or play a role in anemia management,” says Dr. Toros Kapoian, DCI Medical Director and Principal Investigator for one study site.
Dr. Kapoian goes on to say, “With the concerns surrounding ESAs, we want to be sure patients are receiving the correct dose. If they are receiving doses higher than what they may need, they may be put at unnecessary risk. Anything we can do to minimize exposure to these drugs will help to keep patients safe.”
The study has a completion date of March 2014 with published results expected by the end of 2014.
“I want to express my sincere thanks and gratitude to the clinical investigative sites for all their hard work as well as the tremendous support received within DCI and from our physician partners,” says Karen Majchrzak.