Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02010762
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Geert D'Haens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Vitamin D Drug: Placebo Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
Actual Study Start Date : February 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Weekly Vitamin D3 drops 25.000 IU for 6 months following ileocoecal resection
Drug: Vitamin D
25.000 IU oral drops

Placebo Comparator: Placebo
Weekly placebo drops for 6 months following ileocoecal resection
Drug: Placebo
placebo oral drops




Primary Outcome Measures :
  1. 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 Measures :
  1. 1. Clinical CD recurrence measured with CDAI among the 2 groups at week 26 (CDAI ≥220) [ Time Frame: 0-6 months ]
  2. 2. NOD2 gene mutations: the difference in response to vitamin D treatment in patients NOD2+ versus patients NOD2-. [ Time Frame: 0-6 months ]
  3. 3. Difference in significant recurrence among all patients with low vitamin D at baseline [ Time Frame: 0-6 months ]
  4. 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 ]
  5. 5. Any adverse events [ Time Frame: 0-6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010762


Locations
Layout table for location information
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 BK
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Layout table for investigator information
Principal Investigator: Geert D'Haens, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Layout table for additonal information
Responsible Party: Geert D'Haens, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02010762     History of Changes
Other Study ID Numbers: NL.45391.018.13
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Geert D'Haens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Crohn's disease
Vitamin D
Postoperative
Recurrence
Inflammatory bowel disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents