Clinical trial NCT00686751: Immune Effects of Vitamin D in Hemodialysis Patients
Official title: Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Hemodialysis
Inflammatory Response
Cardiovascular Disease
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient stable on chronic hemodialysis for more than 3 months.
* PTH level between 150 - 800 pg/ml.
* Ability to give informed consent.
* Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
* Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
* Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements.

Exclusion Criteria:

* Known active malignancy.
* Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
* PTH levels between 150 pg/mL and 800 pg/mL.
* Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
* Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks.
* Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study.
* Chronic viral infection (HIV, Hepatitis B or C).
* Currently on immunosuppressive medication (steroids, cyclosporine, etc...).
* Hematocrit less than 30 %.
* History of blood disorders other than renal anemia.
* Age of less than 18 years or more than 75 years.
* Hypersensitivity to paricalcitol or any ingredient of the product.
* Parathyroidectomy.
* Participation in another study at the same time.

Primary outcomes:
measure: measurement of pro- and anti-inflammatory cytokines and inflammatory markers
timeFrame: first and second HD treatments for the 4 weeks of the study
Secondary outcomes:
measure: serum calcium level
timeFrame: 24 hours after termination of second HD treatment in week 3 of study
measure: serum phosphate level
timeFrame: 24 hours after termination of second HD treatment in week 3 of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Irving Place Dialysis Center
state: New York
city: New York
country: United States
facility: Upper Manhattan Dialysis Center
state: New York
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
Study officials:
affiliation: Renal Research Institute
name: Nathan W Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: