The effect of Vitamin D3 to prevent postoperative relapse of Crohn*s Disease: a placebo-controlled randomized trial (DETECT)

Phase 4

Completed

Conditions: crohn's disease
inflammatory bowel disease
10017969
10003816
10017998

Registration Number: NL-OMON44853

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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, corrected for albumin
- 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 (sarcoïdosis, 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients with clinically significant endoscopic recurrence<br /><br>(grades i2b, i3 and i4) at 6 months after preventive treatment with vitamin D<br /><br>(or placebo) in the setting of postoperative Crohn*s Disease will be studied.<br /><br>The endoscopic appearance at 6 months postoperatively has reliably been<br /><br>predictive of the ensuing clinical course of the disease. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The proportion of patients in clinical remission. Moreover, the influence of<br /><br>vitamin D treatment will be analysed based on patients* NOD2/CARD15 genotype.<br /><br>Lastly quality of life will be investigated.</p><br>