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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002838-20-NL

Enrollment

142

Registered

2013-09-06

Start date

2013-11-12

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: InVita D3 Pharmaceutical Form: Oral solution INN or Proposed INN: Colecalciferol Other descriptive name: CHOLECALCIFEROL CONCENTRATE Concentration unit: IU international unit(s) Concentra

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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. - 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	—

Measure

Time frame

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. - 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Belgium, Netherlands

Contacts

Public ContactGeert D'Haens

Academic Medical Center

g.dhaens@amc.uva.nl0031205661768

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026