Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Soya Bean oil

+ Vitamin D

Dietary Supplement
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 70 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-ControlledPhase 4
Interventional
Study Start: December 2011
See protocol details

Summary

Principal SponsorUniversity of Dublin, Trinity College
Last updated: July 22, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01792388
Principal SponsorUniversity of Dublin, Trinity College
Last updated: July 22, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel DiseasesCrohn Disease

Criteria

5 inclusion criteria required to participate
18-65 years
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
All patients must fulfill the clinical criteria for diagnosis of CD as defined by Lennard-Jones et al. (1976)
Patients on stable drug therapies for at least 1 month pre-enrolment
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13 exclusion criteria prevent from participating
Alcohol dependency
Antibiotic use in the 4 weeks prior to enrolment
Current use of bisphosphonates
Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active, lymphoma, short bowel syndrome
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Adelaide and Meath Hospital

Dublin, IrelandOpen Adelaide and Meath Hospital in Google Maps

Tallaght Hospital

Dublin, Ireland
Completed2 Study Centers