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Completed

NCT Number: NCT02010762

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

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.

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Key information

Conditions

Crohn's Disease Colonic Diseases Crohn Disease Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Academic Medical Center

Amsterdam, 1105 BK, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

25.000 IU oral drops

Placebo

Drug

placebo oral drops

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial

Acronym: DETECT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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