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Vitd and Barrier Function in IBD | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Vitd and Barrier Function in IBD

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

NCT01792388•University of Dublin, Trinity College

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (2)

Adelaide and Meath Hospital

Dublin, Ireland

Tallaght Hospital

Dublin, Ireland

Key Dates

Start Date

December 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

July 22, 2014

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Vitamin D

DIETARY_SUPPLEMENT

Soya Bean oil

DIETARY_SUPPLEMENT

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vitd and Barrier Function in IBD

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease