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


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Kidney Disease

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

6 months from baseline visit

Safety Issue:

Yes

Principal Investigator

Sharon M Moe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

0707-04

NCT ID:

NCT00749736

Start Date:

July 2008

Completion Date:

July 2012

Related Keywords:

  • Chronic Kidney Disease
  • vitamin D
  • determine
  • normal
  • intrapatient
  • interpatient
  • variability
  • measures
  • immune system
  • Kidney Diseases
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic

Name

Location
Indiana University School of Medicine Indianapolis, Indiana  46204