Clinical trial NCT00749736: The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
Official title: The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: vitamin D
determine
normal
intrapatient
interpatient
variability
measures
immune system
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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. 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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 6 months from baseline visit
Secondary outcomes:
measure: 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.
timeFrame: 6 months from baseline visit.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Sharon M Moe, MD
role: PRINCIPAL_INVESTIGATOR
References: