Vitd and Barrier Function in IBD

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Soya Bean oil; Dietary Supplement: Vitamin D

• Registration Number: NCT01792388
• Lead Sponsor: University of Dublin, Trinity College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soya Bean oil	Soya Bean oil	-
Vitamin D	Vitamin D	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Intestinal Permability from baseline and 3 months	0 and 3 months	Lactulose, Mannitol, Sucralose Test

Secondary Outcome Measures

Name	Time	Method
To assess change in grip strength and associated fatigue markers	Baseline and 3 months
Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months	Baseline and 3months

Trial Locations

Locations (2)

Tallaght Hospital; 🇮🇪 Dublin 24, Ireland

Adelaide and Meath Hospital; 🇮🇪 Dublin, Ireland