Clinical trial NCT01792388: Vitd and Barrier Function in IBD
Official title: Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Vitamin D
Intestinal Permeability
Tara Raftery
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Queen Mary University of London
First posted: 2013-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Intestinal Permability from baseline and 3 months
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months
timeFrame: Baseline and 3months
measure: To assess change in grip strength and associated fatigue markers
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Dublin 24
country: Ireland
facility: Tallaght Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Maria O'Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raftery T, Martineau AR, Greiller CL, Ghosh S, McNamara D, Bennett K, Meddings J, O'Sullivan M. Effects of vitamin D supplementation on intestinal permeability, cathelicidin and disease markers in Crohn's disease: Results from a randomised double-blind placebo-controlled study. United European Gastroenterol J. 2015 Jun;3(3):294-302. doi: 10.1177/2050640615572176.