Crohn's DiseasePhase 4DETECTNCT02010762
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
A Phase 4 study testing Vitamin D in people with Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2013to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, either male or female
- Established CD
- First or second ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
- Able to give written informed consent
- Normal levels of serum calcium at inclusion
- Being able to resume oral intake within 2 weeks after surgery
Who cannot join
- Patients in whom not all visible CD has been resected
- Active fistulizing perianal disease (requiring anti TNF treatment)
- Extensive small bowel resection
- Third, fourth or later ileocolonic resection
- Patients undergoing ileocoecal resection in the Lir!c Trial (NTR 1150, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1150)
- A history of primary hyperparathyroidism
Show all 12Show fewer
- A history of osteoporosis for which calcium and Vitamin D treatment are mandatory
- A history of another granulomatous diseases (sarcoidosis, tuberculosis)
- Pregnant or breastfeeding (at index date) female patients
- Patients undergoing other resections than ileocolonic resections
- Patients who prefer to use open-label vitamin D preparations
- Patients who will continue to use tanning beds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear promising but are hampered by immunogenicity, side effects and high cost.
Vitamin D has recently received a lot of scientific attention and was found to have strong anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally missed its endpoint because of lack of power.
The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in the prevention of postoperative recurrence.
Read the detailed description
Our objective is to study the prophylactic effect of Vitamin D3 to prevent post-operative recurrence of Crohn's disease (CD), with an endoscopic endpoint 6 months after surgery as the primary outcome. Endoscopy has been an established surrogate marker for future clinical relapse. Secondary objectives include clinical recurrence rates at 6 months, the difference in recurrence rates among patients with and without low Vitamin D levels at baseline, the effects of Vitamin D3 on quality of life parameters, resource use and related costs.
ANTICIPATED OUTCOME This study will provide proof of the anti-inflammatory effect of vitamin D, which to our opinion can best be studied in a post-operative setting. Since post-operative recurrence is frequent, a safe and cost-effective therapy is highly needed for this indication. The hypothesis is that patients who receive vitamin D treatment will have less frequent and less severe endoscopic recurrence.
- Conditions
- Crohn's Disease
- Being tested
- Vitamin D, Placebo
- Keywords
- Crohn's disease, Vitamin D, Postoperative, Recurrence, Inflammatory bowel disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Pathologic Processes
- Medical subject headings
- Crohn Disease, Recurrence, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
25.000 IU oral drops
PlaceboDrug
placebo oral drops
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Weekly placebo drops for 6 months following ileocoecal resection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Measured: 0-6 months
Secondary outcomes (5)
1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
Measured: 0-6 months
2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
Measured: 0-6 months
3. Difference in significant recurrence among all patients with low vitamin D at baseline
Measured: 0-6 months
4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
Measured: 0-6 months
5. Any adverse events
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionDec 2017
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert D'Haens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Geert D'Haens, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010762
- Sponsor's protocol ID
- NL.45391.018.13
- Acronym
- DETECT
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2013
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Bruyn JR, Bossuyt P, Ferrante M, West RL, Dijkstra G, Witteman BJ, Wildenberg M, Hoentjen F, Franchimont D, Clasquin E, van der Bilt JD, Tollens T, Bemelman WA, D'Hoore A, Duijvestein M, D'Haens GR; Dutch-Belgian The Effect of Vitamin D3 to Prevent Postoperative Relapse of Crohn's Disease: A Placebo-controlled Randomized Trial Study Group. High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn's Disease in a Randomized Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1573-1582.e5. doi: 10.1016/j.cgh.2020.05.037. Epub 2020 May 24.
PubMed 32461138
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT02010762
- Acronym / sponsor ID
- DETECT / NL.45391.018.13
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Vitamin D, Postoperative, Recurrence, Inflammatory bowel disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Dec 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.
The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear promising but are hampered by immunogenicity, side effects and high cost.
Vitamin D has recently received a lot of scientific attention and was found to have strong anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally missed its endpoint because of lack of power.
The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in the prevention of postoperative recurrence.
Detailed description
Our objective is to study the prophylactic effect of Vitamin D3 to prevent post-operative recurrence of Crohn's disease (CD), with an endoscopic endpoint 6 months after surgery as the primary outcome. Endoscopy has been an established surrogate marker for future clinical relapse. Secondary objectives include clinical recurrence rates at 6 months, the difference in recurrence rates among patients with and without low Vitamin D levels at baseline, the effects of Vitamin D3 on quality of life parameters, resource use and related costs.
ANTICIPATED OUTCOME This study will provide proof of the anti-inflammatory effect of vitamin D, which to our opinion can best be studied in a post-operative setting. Since post-operative recurrence is frequent, a safe and cost-effective therapy is highly needed for this indication. The hypothesis is that patients who receive vitamin D treatment will have less frequent and less severe endoscopic recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin DWeekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection |
| Placebo | Placebo comparator | Drug: PlaceboWeekly placebo drops for 6 months following ileocoecal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, either male or female
- Established CD
- First or second ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
- Able to give written informed consent
- Normal levels of serum calcium at inclusion
Key exclusion criteria (12 listed)
- Patients in whom not all visible CD has been resected
- Active fistulizing perianal disease (requiring anti TNF treatment)
- Extensive small bowel resection
- Third, fourth or later ileocolonic resection
- Patients undergoing ileocoecal resection in the Lir!c Trial (NTR 1150, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1150)
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 D25.000 IU oral drops | Drug | Vitamin D |
| Placeboplacebo oral drops | Drug | Placebo |
Primary outcome
Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Time frame: 0-6 months
5 secondary outcomes
1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
Time frame: 0-6 months
2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
Time frame: 0-6 months
3. Difference in significant recurrence among all patients with low vitamin D at baseline
Time frame: 0-6 months
4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
Time frame: 0-6 months
5. Any adverse events
Time frame: 0-6 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 7 Dec 2017.
- Derived from this study: PubMed 32461138de Bruyn JR, Bossuyt P, Ferrante M, West RL, Dijkstra G, Witteman BJ, Wildenberg M, Hoentjen F, Franchimont D, Clasquin E, van der Bilt JD, Tollens T, Bemelman WA, D'Hoore A, Duijvestein M, D'Haens GR; Dutch-Belgian The Effect of Vitamin D3 to Prevent Postoperative Relapse of Crohn's Disease: A Placebo-controlled Randomized Trial Study Group. High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn's Disease in a Randomized Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1573-1582.e5. doi: 10.1016/j.cgh.2020.05.037. Epub 2020 May 24.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Geert D'Haens, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 D in people with Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 inclusion and 12 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 7 Dec 2017. 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 Netherlands. 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?
Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2. (time frame: 0-6 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 NCT02010762, 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 7 Dec 2017.