Impact of Vitamin D Therapies on Chronic Kidney Disease

April 11, 2016 updated by: Jason Stubbs, MD, University of Kansas Medical Center

Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease

This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.

Vitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.

This study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.

There are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney disease w/GFR<35ml/min
  • Nutritional vitamin D deficiency, defined as 25(OH)D < 25ng/ml
  • Secondary hyperparathyroidism, PTH>75pg/mL

Exclusion Criteria:

  • Active infection
  • Recent hospitalization for acute illness (within last month)
  • Refusal to study participation
  • History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)
  • Allergy to cholecalciferol or calcitriol
  • History of parathyroidectomy
  • Functional renal transplant within 5 years
  • Current treatment with immunosuppressant medications
  • Noncompliance with prescribed medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Cholecalciferol - CKD
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.
Drug: Cholecalciferol - CKD
Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
Other Names:
  • Vitamin D3
Experimental: Group 2: Calcitriol - CKD
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks.
Device: Calcitriol - CKD
Calcitriol 0.25 mcg once daily for 8 weeks
Other Names:
  • 1,25(OH)2D
Experimental: Group 3: Cholecalciferol - non-CKD
Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.
Drug: Cholecalciferol - non-CKD
Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocyte Protein Expression
Time Frame: 8 weeks of therapy
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
8 weeks of therapy
Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
Time Frame: 8 weeks of therapy
8 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Jason Stubbs, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11936

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End-stage Renal Disease (ESRD)

Clinical Trials on Cholecalciferol - CKD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe