Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
NCT Number: NCT00749736
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Indianapolis, Indiana, 46202, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4000 IU of cholecalciferol per day
15 patients will be enrolled in each arm.
1 mcg of doxercalciferol per day
placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula.
15 patients will be enrolled in each arm.
Time frame: 6 months from baseline visit
Time frame: 6 months from baseline visit.
Indiana University
Other
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
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