Status:
COMPLETED
Vitd and Barrier Function in IBD
Lead Sponsor:
University of Dublin, Trinity College
Collaborating Sponsors:
University of Calgary
Queen Mary University of London
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial barrier integrity i...
Eligibility Criteria
Inclusion
- All patients must fulfill the clinical criteria for diagnosis of CD as defined by Lennard-Jones et al. (1976)
- All patients must be in clinical remission for at least 1 month at study entry as defined by a Crohn's Disease Activity Index (CDAI) of \<150
- 18-65 years
- Patients on stable drug therapies for at least 1 month pre-enrolment
- Sufficient English language ability to carry out the study requirements
Exclusion
- Symptomatic CD at study entry including CDAI \>150
- Pregnancy
- Previous extensive small bowel resection (less than 200 cm of viable small bowel or a loss of 50% or more of the small intestine)
- Presence of an ileostomy or colostomy
- Known hypersensitivity to vitamin D
- Hypercalcaemia (corrected serum calcium \> 2.66 mmol/L)
- Those currently using supplemental vitamin D \>800 IU/D
- Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active, lymphoma, short bowel syndrome
- Antibiotic use in the 4 weeks prior to enrolment
- Current use of bisphosphonates
- Renal Impairment, Diabetes Mellitus
- Patients participating in a concurrent RCT
- Alcohol dependency
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01792388
Start Date
December 1 2011
End Date
March 1 2012
Last Update
July 22 2014
Active Locations (2)
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1
Adelaide and Meath Hospital
Dublin, Ireland
2
Tallaght Hospital
Dublin, Ireland