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

Chronic Kidney Disease Clinical Trial

Official title:

The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749736
• Other study ID #: 0707-04
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: March 28, 2013
• Start date: July 2008
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• cholecalciferol
4000 IU of cholecalciferol per day 15 patients will be enrolled in each arm.
• doxercalciferol
1 mcg of doxercalciferol per day
• placebo
placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula. 15 patients will be enrolled in each arm.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months from baseline visit	Yes
Secondary	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.		6 months from baseline visit.	No