Vitd and Barrier Function in IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Soya Bean oil

Group Type PLACEBO_COMPARATOR

Soya Bean oil

Intervention Type DIETARY_SUPPLEMENT

Capsule form

Vitamin D

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Capsule Form

Interventions

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Vitamin D

Capsule Form

Intervention Type DIETARY_SUPPLEMENT

Soya Bean oil

Capsule form

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No