The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease (DETECT)
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|ClinicalTrials.gov Identifier: NCT02010762|
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Vitamin D Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial|
|Actual Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Vitamin D
Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection
Drug: Vitamin D
25.000 IU oral drops
Placebo Comparator: Placebo
Weekly placebo drops for 6 months following ileocoecal resection
placebo oral drops
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010762
|Academic Medical Center|
|Amsterdam, Netherlands, 1105 BK|
|Principal Investigator:||Geert D'Haens, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|