Vitd and Barrier Function in IBD

Crohn's Disease Clinical Trial

— VIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792388
• Other study ID #: vip
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: July 21, 2014
• Start date: December 2011
• Est. completion date: March 2012

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• Vitamin D
Capsule Form
• Soya Bean oil
Capsule form

Locations

Country	Name	City	State
Ireland	Adelaide and Meath Hospital	Dublin
Ireland	Tallaght Hospital	Dublin 24

Sponsors (3)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Queen Mary University of London, University of Calgary

Country where clinical trial is conducted

Ireland, 

Outcome

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