Status:
TERMINATED
Trial of High Dose Vitamin D in Patient's With Crohn's Disease
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Crohn's and Colitis Foundation
Conditions:
Crohn's Disease
Vitamin D Deficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Crohn's disease is more common in areas of the world with less sunlight exposure. Sunlight is a major source of vitamin D. There is some research to suggest that patient's with higher vitamin D levels...
Detailed Description
Subjects are randomized to low or high dose vitamin D, and outcomes including steroid prescriptions, CD-related hospitalizations, CD-related surgeries, and the modified Harvey-Bradshaw Index are measu...
Eligibility Criteria
Inclusion
- Diagnosis of CD
- Age \>= 18 and \<75
- Vitamin D deficiency or insufficiency (serum 25-hydroxyvitamin D \< 30ng/ml)
Exclusion
- Corticosteroid use in the last 4 weeks
- CD-related surgery in the last 6 months
- CD-related hospitalization in the last 4 weeks
- Pregnancy, intended pregnancy during the study period or nursing
- Serum calcium \>10.2 mg/dL
- History of primary sclerosing cholangitis
- History of undergoing an ileal pouch-anal anastomosis
- Current active perianal disease
- History of nephrolithiasis in the past 2 years
- Anticipated change in therapy in the next 30 days (steroids, biologic initiation)
- modified Harvey-Bradshaw Index of 10 or more
- History of decreased renal function (glomerular filtration rate \<30ml/min based on MDRD) or polycystic kidney disease
- History of sarcoidosis
- History of hyperparathyroidism
- Any other chronic condition that may preclude high doses of Vitamin D such as lymphoma
- Concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone
- Osteoporosis
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02208310
Start Date
April 1 2015
End Date
April 1 2016
Last Update
October 6 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University
Indianapolis, Indiana, United States, 46001
2
University of Iowa
Iowa City, Iowa, United States, 55240
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599