Status:
COMPLETED
Vitamin D in Pediatric Crohn's Disease
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
McMaster University
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
8-18 years
Phase:
PHASE4
Brief Summary
Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic relapsing inflammatory disorder of the digestive system. CD affects \~112,000 individuals in Canada, of whom ...
Detailed Description
Trial Objectives: Our primary hypothesis is that a greater proportion of pediatric CD patients will achieve optimal 25OHD concentration (\> 75 nmol/L) on 2000 IU/d than 400 IU/d Vitamin D. Our primary...
Eligibility Criteria
Inclusion
- Patients will be eligible to participate if they have a diagnosis of CD, are between 8-18 years of age, and have been in remission for at least 4 weeks as indicated by a PCDAI \<10.
Exclusion
- Patients will be ineligible if they have active disease with a PCDAI \> 10, taking corticosteroids, or taking more than 400 IU Vitamin D at enrollment.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01187459
Start Date
September 1 2010
End Date
February 1 2012
Last Update
February 14 2012
Active Locations (2)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
2
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5