The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease

Phase 1

Conditions: Crohn's Disease
MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-002838-20-BE

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 142

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
-Serum calcium levels at screening not exceeding upper limit of normal according to local lab reference ranges
-Being able to resume oral intake within 2 weeks after surgery

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the proportion of patients with clinically significant endoscopic recurrence (Rutgeerts grades i2b, i3 and i4) at 6 months after preventive treatment with vitamin D is different from the patients treated with placebo --> the antiinflammatory effect of Vitamin D3;Secondary Objective: - The proportion of patients in clinical remission. <br>- The influence of vitamin D treatment based on patients’ NOD2/CARD15 genotype.<br>- Quality of life ;Primary end point(s): Endoscopic recurrence at 6 months postoperatively;Timepoint(s) of evaluation of this end point: 6 months after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Clinical Recurrence rate at 6 months<br>-Difference in significant recurrence among all patients with low vitamin D at baseline<br>-The difference in response to vitamin D treatment in patients with NOD2 mutation versus patients without NOD2 mutation<br>-To investigate if the urine metabolome is different in patients responding to vitamin D treatment<br>- Quality of life<br>;Timepoint(s) of evaluation of this end point: 6 months after randomization