Chronic Kidney Disease Clinical Trial
Official title:
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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