Crohn's DiseasePhase 4VITD-CDNCT01369667
Vitamin D Supplementation in Adult Crohn's Disease
A Phase 4 study testing Vitamin D3 in people with Crohn's Disease, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2012to May 2015
- 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 75 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 Crohn's disease.
- Subjects must have inactive CD as defined by CDAI < 150
- CRP </=10 mg/L.
Who cannot join
- Pregnant and lactating women.
- Known hypersensitivity to vitamin D.
- Hypercalcaemia
- Current supplemental intake of vitamin D3 >800 IU/D.
- Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.
- Participation in a concurrent clinical trial.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital,
Dublin
About this study
Official title: Vitamin D and Immunomodulation: Effects in Crohn's Disease
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- Vitamin D3, Placebo
- 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 D3Dietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Active comparator | Capsule, one taken daily Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Capsule, one taken daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionMay 2015
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Principal investigator, Tara Raftery, University of Dublin, Trinity College
- Investigators
- Maria O'Sullivan, PhD, Principal investigator, TCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369667
- Sponsor's protocol ID
- VITD/CD/01
- Acronym
- VITD-CD
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2011
- Last updated
- 18 Aug 2015
- Results posted
- No
Publications
O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12.
PubMed 30649836
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Immunomodulation: Effects in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01369667
- Acronym / sponsor ID
- VITD-CD / VITD/CD/01
- Conditions
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jun 2011 (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.
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Active comparator | Dietary Supplement: Vitamin D3Capsule, one taken daily |
| Placebo | Placebo comparator | Other: PlaceboCapsule, one taken daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must fulfill the clinical criteria for diagnosis of Crohn's disease.
- Subjects must have inactive CD as defined by CDAI < 150
- CRP </=10 mg/L.
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Known hypersensitivity to vitamin D.
- Hypercalcaemia
- Current supplemental intake of vitamin D3 >800 IU/D.
- Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma.
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 D3 | Dietary supplement | vitamin D |
| Placebo | Other | Placebo |
Primary outcome
Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period.
Time frame: 12 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 18 Aug 2015.
- Derived from this study: PubMed 30649836O'Sullivan F, Raftery T, van Weele M, van Geffen J, McNamara D, O'Morain C, Mahmud N, Kelly D, Healy M, O'Sullivan M, Zgaga L. Sunshine is an Important Determinant of Vitamin D Status Even Among High-dose Supplement Users: Secondary Analysis of a Randomized Controlled Trial in Crohn's Disease Patients. Photochem Photobiol. 2019 Jul;95(4):1060-1067. doi: 10.1111/php.13086. Epub 2019 Mar 12.
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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
TCD
1 site 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 D3 in people with Crohn's Disease, run by University of Dublin, Trinity College at 1 site 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 3 inclusion and 6 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period. (time frame: 12 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 NCT01369667, 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 18 Aug 2015.