Crohn's Disease Clinical Trial
— VIPOfficial title:
Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission
Verified date | July 2014 |
Source | University of Dublin, Trinity College |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Research Ethics Committee |
Study type | Interventional |
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 is therefore essential for intestinal homeostasis. Vitamin D may have a critical role in improving barrier function.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Ireland | Adelaide and Meath Hospital | Dublin | |
Ireland | Tallaght Hospital | Dublin 24 |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College | Queen Mary University of London, University of Calgary |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Intestinal Permability from baseline and 3 months | Lactulose, Mannitol, Sucralose Test | 0 and 3 months | No |
Secondary | Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months | Baseline and 3months | No | |
Secondary | To assess change in grip strength and associated fatigue markers | Baseline and 3 months | No |
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