The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease

Crohn's Disease Clinical Trial

— DETECT  

Official title:

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010762
• Other study ID #: NL.45391.018.13
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 6, 2017
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Vitamin D
25.000 IU oral drops
• Placebo
placebo oral drops

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score =i2.		0-6 months
Secondary	1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI =220)		0-6 months
Secondary	2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.		0-6 months
Secondary	3. Difference in significant recurrence among all patients with low vitamin D at baseline		0-6 months
Secondary	4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)		0-6 months
Secondary	5. Any adverse events		0-6 months