- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835691
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
50,000 units once a week for 12 weeks
|
Experimental: Vitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks
|
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
Investigators
- Principal Investigator: Jason Stubbs, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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-
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