The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00749736
First received: September 8, 2008
Last updated: March 28, 2013
Last verified: March 2013

September 8, 2008
March 28, 2013
July 2008
July 2012   (final data collection date for primary outcome measure)
The primary endpoint will be the change in CD4+/CD8+ ratio and other flow cytometry parameters based on the results of Aims 1 and 2, TH1/TH2 cytokine profile, and conversion from anergic to reactive skin testing. [ Time Frame: 6 months from baseline visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00749736 on ClinicalTrials.gov Archive Site
A change in mean blood pressure from one week of ambulatory measures, random protein/creatinine ratio, and differences in muscle strength by timed up and go test, and measures of quality of life using the SF36 forms. [ Time Frame: 6 months from baseline visit. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.

Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D). Patients with CKD are also known to have abnormalities in their immune cells, increased susceptibility to infection and increased prevalence of malignancies. In patients without kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it is logical that patients with CKD who are vitamin D deficient may benefit from repletion of vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of calcitriol or its analogues. However, no interventional data demonstrates that repletion positively impacts immune status in CKD patients. To test this hypothesis, a large interventional study will be required. However, prior to conducting this study, several important steps are needed. The present proposal aims to generate the necessary data to appropriately plan and conduct a future multi center interventional study. Specifically, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from Indiana University Affiliated Nephrology Clinics and determine

  1. if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D.
  2. how reproducible these changes are on repeat testing and
  3. if repletion of vitamin D changes these cells and immune blood tests in a small pilot study.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Chronic Kidney Disease
  • Dietary Supplement: cholecalciferol

    4000 IU of cholecalciferol per day

    15 patients will be enrolled in each arm.

  • Dietary Supplement: doxercalciferol
    1 mcg of doxercalciferol per day
  • Dietary Supplement: placebo

    placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula.

    15 patients will be enrolled in each arm.

  • Active Comparator: 1
    4000 IU of cholecalciferol per day
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: 2
    1 mcg of doxercalciferol per day.
    Intervention: Dietary Supplement: doxercalciferol
  • Placebo Comparator: 3
    placebo for six months
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • no administration of any form of vitamin D supplement or therapy in the last 60 days except for that in a multi vitamin
  • Hgb >10 mg/dl
  • able to sign informed consent
  • CKD stage 3 (GFR 30-59ml/min) or stage 4 (GFR 15-29ml/min)
  • iPTH <70pg/ml for stage 3 or iPTH <110pg/ml for stage 4
  • calcidiol levels < or +20ng/ml

Exclusion Criteria:

  • initial corrected Calcium >9.7mg/dl
  • initial serum Phosphorus >5.0mg/dl
  • initial standardized blood pressure of >160/100
  • history of significant liver disease or cirrhosis
  • anticipated requirement for dialysis in 6 months
  • malabsorption, severe chronic diarrhea, or ileostomy
  • no calcimimetic or active vitamin D therapy 60 days prior to enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00749736
0707-04
Yes
Indiana University
Indiana University
Not Provided
Principal Investigator: Sharon M Moe, MD Indiana University School of Medicine
Indiana University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP