The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
Information source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Vitamin D (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Official(s) and/or principal investigator(s): Geert D'Haens, MD, PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall contact: Jessica de Bruyn, MD, Phone: 0031205668873, Email: j.r.debruyn@amc.uva.nl
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.
Clinical Details
Official title: The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Proportion of patients with clinically significant endoscopic recurrence at 6 months of vitamin D3 treatment postoperatively, defined as endoscopic Rutgeerts' score ≥i2.
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jessica de Bruyn, MD, Phone: 0031205668873, Email: j.r.debruyn@amc.uva.nl
Academic Medical Center, Amsterdam 1105 BK, Netherlands; Recruiting Jessica de Bruyn, MD, Phone: 0031205668873, Email: j.r.debruyn@amc.uva.nl Geert D'Haens, MD, PhD, Phone: 0031205661768, Email: g.dhaens@amc.uva.nl
Additional Information
Starting date: December 2013
Last updated: January 13, 2015
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