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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn's Disease focused on measuring Crohn's disease, Vitamin D, Postoperative, Recurrence, Inflammatory bowel disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Pathologic Processes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection

Weekly placebo drops for 6 months following ileocoecal resection

Outcomes

Primary Outcome Measures

Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.

Secondary Outcome Measures

1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
3. Difference in significant recurrence among all patients with low vitamin D at baseline
4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
5. Any adverse events

Full Information

First Posted
December 10, 2013
Last Updated
December 6, 2017
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02010762
Brief Title
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
Acronym
DETECT
Official Title
The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Vitamin D, Postoperative, Recurrence, Inflammatory bowel disease, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Pathologic Processes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Weekly placebo drops for 6 months following ileocoecal resection
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
25.000 IU oral drops
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo oral drops
Primary Outcome Measure Information:
Title
Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Time Frame
0-6 months
Secondary Outcome Measure Information:
Title
1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220)
Time Frame
0-6 months
Title
2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-.
Time Frame
0-6 months
Title
3. Difference in significant recurrence among all patients with low vitamin D at baseline
Time Frame
0-6 months
Title
4. Quality of life, measured by one validated questionnaire for IBD patients (IBD-Q) and two general questionnaires (SF-36 and EuroQol)
Time Frame
0-6 months
Title
5. Any adverse events
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert D'Haens, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 BK
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32461138
Citation
de Bruyn JR, Bossuyt P, Ferrante M, West RL, Dijkstra G, Witteman BJ, Wildenberg M, Hoentjen F, Franchimont D, Clasquin E, van der Bilt JD, Tollens T, Bemelman WA, D'Hoore A, Duijvestein M, D'Haens GR; Dutch-Belgian The Effect of Vitamin D3 to Prevent Postoperative Relapse of Crohn's Disease: A Placebo-controlled Randomized Trial Study Group. High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn's Disease in a Randomized Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1573-1582.e5. doi: 10.1016/j.cgh.2020.05.037. Epub 2020 May 24.
Results Reference
derived

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

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