Vitd and Barrier Function in IBD (VIP)

July 21, 2014 updated by: Tara Raftery, University of Dublin, Trinity College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Adelaide and Meath Hospital
      • Dublin 24, Ireland
        • Tallaght Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D
Dietary supplement: Vitamin D
Capsule Form
Placebo Comparator: Soya Bean oil
Dietary supplement: Soya Bean oil
Capsule form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Intestinal Permability from baseline and 3 months
Time Frame: 0 and 3 months
Lactulose, Mannitol, Sucralose Test
0 and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months
Time Frame: Baseline and 3months
Baseline and 3months
To assess change in grip strength and associated fatigue markers
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

University of Calgary
Queen Mary University of London

Investigators

  • Principal Investigator: Maria O'Sullivan, PhD, University of Dublin, Trinity College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on Soya Bean oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe