Vitd and Barrier Function in IBD

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission

Conditions
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Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Soya Bean oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Soya Bean oil<br> | Dietary Supplement: Soya Bean oil<br>* Capsule form<br>|
| Active Comparator: Vitamin D<br> | Dietary Supplement: Vitamin D<br>* Capsule Form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Intestinal Permability from baseline and 3 months | Lactulose, Mannitol, Sucralose Test | 0 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Vitamin D, Intestinal Permeability, Tara Raftery