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

NCT00749736 | Completed Phase 4 DMC

• 1 other identifier: 0707-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D.
2. 2.how reproducible these changes are on repeat testing and
3. 3.if repletion of vitamin D changes these cells and immune blood tests in a small pilot study.

Conditions

Chronic Kidney Disease

Keywords

vitamin D; determine; normal; intrapatient; interpatient; variability; measures; immune system

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

Study Arms (3)

1

ACTIVE COMPARATOR

4000 IU of cholecalciferol per day

Dietary Supplement: cholecalciferol

2

ACTIVE COMPARATOR

1 mcg of doxercalciferol per day.

Dietary Supplement: doxercalciferol

3

PLACEBO COMPARATOR

placebo for six months

Dietary Supplement: placebo

Interventions

cholecalciferol DIETARY_SUPPLEMENT

4000 IU of cholecalciferol per day 15 patients will be enrolled in each arm.

1

doxercalciferol DIETARY_SUPPLEMENT

1 mcg of doxercalciferol per day

2

placebo DIETARY_SUPPLEMENT

placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula. 15 patients will be enrolled in each arm.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cholecalciferol; 1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sharon M Moe, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

US (1)