Crohn's DiseasePhase 4VIPNCT01792388
Vitd and Barrier Function in IBD
A Phase 4 study testing Vitamin D and Soya Bean oil in people with Crohn's Disease, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Vitamin D and Soya Bean oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesIreland
- Study dates
- Dec 2011to Mar 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Crohn's Disease
- Being tested
- Vitamin D, Soya Bean oil
- Keywords
- Crohn's Disease, Vitamin D, Intestinal Permeability, Tara Raftery
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Capsule Form
Soya Bean oilDietary supplement
Capsule form
| Study group | Role | What they receive |
|---|---|---|
| Soya Bean oil | Placebo comparator | Not described Receives: Dietary Supplement: Soya Bean oil |
| Vitamin D | Active comparator | Not described Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Intestinal Permability from baseline and 3 months
Lactulose, Mannitol, Sucralose Test
Measured: 0 and 3 months
Secondary outcomes (2)
Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months
Measured: Baseline and 3months
To assess change in grip strength and associated fatigue markers
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Queen Mary University of London
- Responsible party
- Principal investigator, Tara Raftery, University of Dublin, Trinity College
- Investigators
- Maria O'Sullivan, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792388
- Sponsor's protocol ID
- vip
- Acronym
- VIP
- Status last verified
- Jul 2014
- First submitted
- 19 Dec 2012
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission
- ClinicalTrials.gov ID
- NCT01792388
- Acronym / sponsor ID
- VIP / vip
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Vitamin D, Intestinal Permeability, Tara Raftery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- University of Calgary, Queen Mary University of London
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soya Bean oil | Placebo comparator | Dietary Supplement: Soya Bean oil |
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DCapsule Form | Dietary supplement | Vitamin D |
| Soya Bean oilCapsule form | Dietary supplement | Soya Bean oil |
Primary outcome
Change from Baseline Intestinal Permability from baseline and 3 months
Time frame: 0 and 3 months
Lactulose, Mannitol, Sucralose Test
2 secondary outcomes
Change in Inflammatory and antimicrobial peptide levels from baseline to 3 months
Time frame: Baseline and 3months
To assess change in grip strength and associated fatigue markers
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Derived from this study: PubMed 26137304Raftery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria O'Sullivan, PhD principal investigator
University of Dublin, Trinity College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D and Soya Bean oil in people with Crohn's Disease, run by University of Dublin, Trinity College at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Intestinal Permability from baseline and 3 months (time frame: 0 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.