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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
  Purpose

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.

Condition Intervention Phase
Chronic Kidney Disease
Dietary Supplement: cholecalciferol
Dietary Supplement: doxercalciferol
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
4000 IU of cholecalciferol per day
Dietary Supplement: cholecalciferol

4000 IU of cholecalciferol per day

15 patients will be enrolled in each arm.

Active Comparator: 2
1 mcg of doxercalciferol per day.
Dietary Supplement: doxercalciferol
1 mcg of doxercalciferol per day
Placebo Comparator: 3
placebo for six months
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749736

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Sharon M Moe, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00749736     History of Changes
Other Study ID Numbers: 0707-04
Study First Received: September 8, 2008
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
vitamin D
determine
normal
intrapatient
interpatient
variability
measures
immune system

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
1 alpha-hydroxyergocalciferol
Cholecalciferol
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014