Status:
COMPLETED
The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
Lead Sponsor:
Indiana University
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00749736
Start Date
July 1 2008
End Date
July 1 2012
Last Update
March 29 2013
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202