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Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2 (ergocalciferol)
Vitamin D3 (cholecalciferol)
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Vitamin D, Vitamin D2, Vitamin D3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vitamin D2 (ergocalciferol)

Vitamin D3 (cholecalciferol)

Arm Description

50,000 units once a week for 12 weeks

50,000 units once a week for 12 weeks

Outcomes

Primary Outcome Measures

Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)

Secondary Outcome Measures

Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)
Change in total serum 25(OH)D (ng/mL)
Change in serum intact parathyroid hormone (PTH) (pg/mL)

Full Information

First Posted
April 12, 2013
Last Updated
October 17, 2017
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01835691
Brief Title
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
Official Title
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Vitamin D, Vitamin D2, Vitamin D3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D2 (ergocalciferol)
Arm Type
Experimental
Arm Description
50,000 units once a week for 12 weeks
Arm Title
Vitamin D3 (cholecalciferol)
Arm Type
Experimental
Arm Description
50,000 units once a week for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2 (ergocalciferol)
Intervention Description
50,000 units once a week for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (cholecalciferol)
Intervention Description
50,000 units once a week for 12 weeks
Primary Outcome Measure Information:
Title
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
Time Frame
Baseline to immediately post-therapy (week 12)
Secondary Outcome Measure Information:
Title
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
Title
Change in total serum 25(OH)D (ng/mL)
Time Frame
week 12 to week 18
Title
Change in serum intact parathyroid hormone (PTH) (pg/mL)
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Stubbs, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease

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