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The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749736
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
Indiana University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: cholecalciferol Dietary Supplement: doxercalciferol Dietary Supplement: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
Study Start Date : July 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
4000 IU of cholecalciferol per day
Dietary Supplement: cholecalciferol

4000 IU of cholecalciferol per day

15 patients will be enrolled in each arm.

Active Comparator: 2
1 mcg of doxercalciferol per day.
Dietary Supplement: doxercalciferol
1 mcg of doxercalciferol per day

Placebo Comparator: 3
placebo for six months
Dietary Supplement: placebo

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

15 patients will be enrolled in each arm.

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749736

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United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Principal Investigator: Sharon M Moe, MD Indiana University School of Medicine
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Responsible Party: Indiana University Identifier: NCT00749736    
Other Study ID Numbers: 0707-04
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Indiana University:
vitamin D
immune system
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
1 alpha-hydroxyergocalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents