Immune Effects of Vitamin D in Hemodialysis Patients
The purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. We want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin D administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.
End Stage Renal Disease
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients|
- measurement of pro- and anti-inflammatory cytokines and inflammatory markers [ Time Frame: first and second HD treatments for the 4 weeks of the study ] [ Designated as safety issue: No ]
- serum calcium level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ] [ Designated as safety issue: Yes ]
- serum phosphate level [ Time Frame: 24 hours after termination of second HD treatment in week 3 of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
There is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks:
Phase 1: administration of study medication at the end of hemodialysis treatment.
Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis.
Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686751
|United States, New York|
|Upper Manhattan Dialysis Center|
|New York, New York, United States, 10025|
|Irving Place Dialysis Center|
|New York, New York, United States, 10003|
|Yorkville Dialysis Center|
|New York, New York, United States, 10128|
|Principal Investigator:||Nathan W Levin, MD||Renal Research Institute|