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

• Register: EUCTR
• Last refreshed on: 29 January 2018
• Main ID: EUCTR2013-002838-20-NL
• Date of registration: 06/09/2013
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center
• Public title: The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease
• Scientific title: The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT
• Date of first enrolment: 12/11/2013
• Target sample size: 142
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002838-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: yes; Other trial design description: patients will be stratified based on their vitamin D level; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Netherlands

Contacts

• Name: Geert D'Haens
• Affiliation: Academic Medical Center

• Name: Geert D'Haens
• Affiliation: Academic Medical Center

Key inclusion & exclusion criteria

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
- Levels of serum calcium at inclusion not exceeding upper limit of normal
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn's Disease
MedDRA version: 18.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: InVita D3
Pharmaceutical Form: Oral solution
INN or Proposed INN: Colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 25000-
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - The proportion of patients in clinical remission.
- The influence of vitamin D treatment based on patients’ NOD2/CARD15 genotype.
- 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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: 6 monhts after randomization

Secondary end point(s): - Clinical Recurrence rate at 6 months
- Difference in significant recurrence among all patients with low vitamin D at baseline
- The difference in response to vitamin D treatment in patients with NOD2 mutation versus patients without NOD2 mutation
- To investigate if the urine metabolome is different in patients responding to vitamin D treatment
- Quality of life

Secondary ID(s)

NL.45391.018.13

Source(s) of Monetary Support

Academic Medical Center