DCI Conducts Oral Vitamin D Study

Study to Determine Safety and Effects of Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
NASHVILLE, TN (May 31, 2012)

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.

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. The DCI study will conduct 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 kidney community has traditionally only used one type of vitamin D, yet we know that different types of vitamin D do different things.” states Dr. Richard Muther, Medical Director and Principal Investigator for one study site.
Dr. Kapoian mentions, “With a lot of other industry sponsored studies there is a potential for bias…With DCI there is no secondary gain. We are doing this for the sole purpose of helping the patients. It’s science at its purest.”

“Doctors have questions that are important and different from what a lab or pharmaceutical company may have. This study comes from real doctors taking care of real patients,” says Dr. Muther.

“From a medical director standpoint, I view DCI as a leader in the [dialysis] industry. The USRDS confirms what we’ve known all along with DCI having the lowest hospitalization and mortality ratios among national providers. I feel DCI should be leading the charge when it comes to research in dialysis. An organization that centers on patient advocacy should be designing and running these clinical trials. Hopefully, this is the first of many studies initiated by DCI,” says Dr. Toros Kapoian.
The study, which needs to enroll 276 subjects with a low vitamin D level in order to answer the study’s primary outcome, has an expected completion date of March 2014.
Participants are still being recruited in Albany, GA; Columbia and Kansas City, MO; and in Omaha, NE.
For more information regarding the study, contact Karen Majchrzak, DCI Director of Clinical Research, at Karen.Majchrzak@dciinc.org.