Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

October 17, 2017 updated by: Jason Stubbs, MD, University of Kansas Medical Center
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?

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 various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group.

This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.

Study Type

Interventional

Enrollment (Actual)

44

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 and above
  • Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV)
  • Vitamin D insufficiency (25-hydroxyvitamin D level < 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level

Exclusion Criteria:

  • Current treatment with cholestyramine
  • Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea.
  • Liver cirrhosis
  • Known current substance abuse
  • Current treatment with immunosuppressant medications
  • Presence of chronic infection
  • History of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, Crohns disease)
  • Currently receiving high-dose vitamin D replacement (avg dose of ≥ 3,000 U per day) or "active" vitamin D analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin D).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D2 (ergocalciferol)
50,000 units once a week for 12 weeks
Dietary supplement: Vitamin D2 (ergocalciferol)
50,000 units once a week for 12 weeks
Experimental: Vitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks
Dietary supplement: Vitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
Time Frame: Baseline to immediately post-therapy (week 12)
Baseline to immediately post-therapy (week 12)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)
Time Frame: Baseline to immediately post-therapy (week 12), and week 12 to week 18
Baseline to immediately post-therapy (week 12), and week 12 to week 18
Change in total serum 25(OH)D (ng/mL)
Time Frame: week 12 to week 18
week 12 to week 18
Change in serum intact parathyroid hormone (PTH) (pg/mL)
Time Frame: Baseline to week 12
Baseline to week 12

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, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12861

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.

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