Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
1 other identifier
interventional
44
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 12, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 19, 2017
October 1, 2017
3.7 years
April 12, 2013
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
Baseline to immediately post-therapy (week 12)
Secondary Outcomes (3)
Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)
Baseline to immediately post-therapy (week 12), and week 12 to week 18
Change in total serum 25(OH)D (ng/mL)
week 12 to week 18
Change in serum intact parathyroid hormone (PTH) (pg/mL)
Baseline to week 12
Study Arms (2)
Vitamin D2 (ergocalciferol)
EXPERIMENTAL50,000 units once a week for 12 weeks
Vitamin D3 (cholecalciferol)
EXPERIMENTAL50,000 units once a week for 12 weeks
Interventions
50,000 units once a week for 12 weeks
50,000 units once a week for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Stubbs, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 12, 2013
First Posted
April 19, 2013
Study Start
October 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 19, 2017
Record last verified: 2017-10