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CompletedNCT01792388VIPUpdated Jul 22, 2014

Vitd and Barrier Function in IBD

A Phase 4 interventional study of Vitamin D and Soya Bean oil in Crohn's Disease, sponsored by University of Dublin, Trinity College. Completed at 2 sites in Ireland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-22.

Sponsored by University of Dublin, Trinity College · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Crohn's Disease

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Keywords

  • Crohn's Disease
  • Vitamin D
  • Intestinal Permeability
  • Tara Raftery
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 30 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University of Dublin, Trinity College is the lead sponsor of 72 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Placebo comparator
    Soya Bean oil

    Dietary Supplement: Soya Bean oil

  • Active comparator
    Vitamin D

    Dietary Supplement: Vitamin D

Interventions

  • Dietary supplementVitamin D

    Capsule Form

  • Dietary supplementSoya Bean oil

    Capsule form

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What researchers measure

Primary outcomes

  1. Change from Baseline Intestinal Permability from baseline and 3 months

    Lactulose, Mannitol, Sucralose Test

    Time frame: 0 and 3 months

Secondary outcomes

  1. Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months

    Time frame: Baseline and 3months

  2. To assess change in grip strength and associated fatigue markers

    Time frame: Baseline and 3 months

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Study locations

2 sites
  • Tallaght Hospital
    Dublin 24, Ireland
  • Adelaide and Meath Hospital
    Dublin, Ireland
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References and documents

Publications

  • Raftery T, Martineau AR, Greiller CL, Ghosh S, McNamara D, Bennett K, Meddings J, O'Sullivan M. Effects of vitamin D supplementation on intestinal permeability, cathelicidin and disease markers in Crohn's disease: Results from a randomised double-blind placebo-controlled study. United European Gastroenterol J. 2015 Jun;3(3):294-302. doi: 10.1177/2050640615572176. PubMed 26137304 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01792388
Lead sponsor
University of Dublin, Trinity College
Collaborators
University of Calgary, Queen Mary University of London
Responsible party
Tara Raftery (Dr. Maria O'Sullivan, PhD, University of Dublin, Trinity College) — Principal investigator
First posted
Feb 15, 2013
Start date
Dec 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jul 22, 2014

Study contacts

Maria O'Sullivan, PhD
principal investigator · University of Dublin, Trinity College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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