Crohn's Disease
Conditions
Keywords
Crohn's Disease, Vitamin D, Intestinal Permeability, Tara Raftery
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 is therefore essential for intestinal homeostasis. Vitamin D may have a critical role in improving barrier function.
Interventions
DIETARY_SUPPLEMENTVitamin D
Capsule Form
DIETARY_SUPPLEMENTSoya Bean oil
Capsule form
Sponsors
University of Calgary
Queen Mary University of London
University of Dublin, Trinity College
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Intestinal Permability from baseline and 3 months | 0 and 3 months | Lactulose, Mannitol, Sucralose Test |
Secondary
| Measure | Time frame |
|---|---|
| Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months | Baseline and 3months |
| To assess change in grip strength and associated fatigue markers | Baseline and 3 months |
Countries
Ireland
Outcome results
None listed