Status:
COMPLETED
The Vitamin D in Pediatric Crohn's Disease
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Crohn's Disease
Eligibility:
All Genders
9-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity, in children ...
Detailed Description
Crohn's disease is a chronic inflammatory condition affecting all segments of the digestive tract from the mouth to the anus. This condition is associated with an increased risk of relapses throughout...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- \- Diagnosis of CD by the usual clinical, endoscopic and histological criteria and classified according to the Paris classification
- Age at randomization between 9 and 18 years inclusively
- Interval between diagnosis and randomization between 2 weeks and 6 months after the diagnosis
- Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 30 at inclusion
- Concurrent treatment with corticosteroids and/or enteral nutrition and/or thiopurines (azathioprine, 6-mercaptopurine) and/or methotrexate and/or 5-aminosalicylic acid (5-ASA) and/or TNF-α inhibitors (Infliximab, Adalimumab).
Exclusion
- Patient diagnosed with severe complex perianal fistulizing CD (defined as the presence at diagnosis of a high intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric complex perianal fistula)
- Known chronic liver cholestasis (defined by an elevation of conjugated bilirubin and/or gamma glutamyl transferase \> 3 upper limit normal)
- Known renal dysfunction requiring chronic dialysis or creatinine ≥ 100 micromol/L.
- Known congenital bone disease
- Known cystic fibrosis or other exocrine pancreatic insufficiency.
- Currently treated with anticonvulsants metabolized through cytochrome P-450
- Unable to take oral capsule form.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02186275
Start Date
February 1 2016
End Date
December 20 2019
Last Update
September 22 2020
Active Locations (10)
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1
Edmonton Clinic Health Academy
Edmonton, Alberta, Canada, T6G 1C9
2
University of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
3
Health Science Center Pediatric
Winnipeg, Manitoba, Canada, R3A 1R9
4
Janeway Children's Health Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6