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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792388
Other study ID # vip
Secondary ID
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


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
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