NCT01792388

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

December 19, 2012

Last Update Submit

July 21, 2014

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseVitamin DIntestinal PermeabilityTara Raftery

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Intestinal Permability from baseline and 3 months

    Lactulose, Mannitol, Sucralose Test

    0 and 3 months

Secondary Outcomes (2)

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

    Baseline and 3months

  • To assess change in grip strength and associated fatigue markers

    Baseline and 3 months

Study Arms (2)

Soya Bean oil

PLACEBO COMPARATOR
Dietary Supplement: Soya Bean oil

Vitamin D

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

Capsule Form

Vitamin D
Soya Bean oilDIETARY_SUPPLEMENT

Capsule form

Soya Bean oil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years
  • Patients on stable drug therapies for at least 1 month pre-enrolment
  • Sufficient English language ability to carry out the study requirements

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Adelaide and Meath Hospital

Dublin, Ireland

Location

Tallaght Hospital

Dublin, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 26137304DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Vitamin DSoybean Oil

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Maria O'Sullivan, PhD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Maria O'Sullivan, PhD

Study Record Dates

First Submitted

December 19, 2012

First Posted

February 15, 2013

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

IE(2)