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OpenTrials
Completed

NCT Number: NCT00749736

The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

4000 IU of cholecalciferol per day

15 patients will be enrolled in each arm.

doxercalciferol

Dietary Supplement

1 mcg of doxercalciferol per day

Placebo

Dietary Supplement

placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula.

15 patients will be enrolled in each arm.

Primary outcomes

  1. 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.

    Time frame: 6 months from baseline visit

Secondary outcomes

  1. 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.

    Time frame: 6 months from baseline visit.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2008
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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