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

Sponsored by:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00749736

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

if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D.
how reproducible these changes are on repeat testing and
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 IV

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.

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 ]

Estimated Enrollment:	100
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 4000 IU of cholecalciferol per day	Dietary Supplement: cholecalciferol 4000 IU of cholecalciferol per day 15 patients will be enrolled in each arm.
2: Active Comparator 1 mcg of doxercalciferol per day.	Dietary Supplement: doxercalciferol 1 mcg of doxercalciferol per day
3: Placebo Comparator 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

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

Contacts

Contact: Sharon M Moe, MD	317-278-2868	smoe@iupui.edu
Contact: Mary A Chambers, RN	317-274-7580	marycham@iupui.edu

Locations

United States, Indiana
Indiana University School of Medicine	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sharon M Moe, MD 317-278-2870 smoe@iupui.edu
Contact: Mary A Chambers, RN 317-274-7580 marycham@iupui.edu

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 Department of Medicine ( Sharon M. Moe, MD )
Study ID Numbers:	0707-04
Study First Received:	September 8, 2008
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00749736 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

vitamin D
determine
normal
intrapatient

interpatient
variability
measures
immune system

Study placed in the following topic categories:

Cholecalciferol
Renal Insufficiency
Kidney Failure, Chronic
Trace Elements
Bone Density Conservation Agents
1 alpha-hydroxyergocalciferol
Vitamin D

Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Kidney Diseases
Micronutrients
Kidney Failure

Additional relevant MeSH terms:

Cholecalciferol
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Kidney Failure, Chronic
Bone Density Conservation Agents
Pharmacologic Actions
Vitamin D

1 alpha-hydroxyergocalciferol
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Kidney Diseases
Micronutrients
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009