This trial will provide definitive answers with regard to the anti-inflammatory effects of Vitamin D in Crohn*s disease.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of patients with clinically significant endoscopic recurrence
(grades i2b, i3 and i4) at 6 months after preventive treatment with vitamin D
(or placebo) in the setting of postoperative Crohn*s Disease will be studied.
The endoscopic appearance at 6 months postoperatively has reliably been
predictive of the ensuing clinical course of the disease.
Secondary outcome
The proportion of patients in clinical remission. Moreover, the influence of
vitamin D treatment will be analysed based on patients* NOD2/CARD15 genotype.
Lastly quality of life will be investigated.
Background summary
The majority of patients with Crohn*s disease 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 IBD.
Medical treatments to prevent recurrence have had limited effect. Anti-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 Crohn*s
disease can best be studied in the prevention of postoperative recurrence.
Study objective
This trial will provide definitive answers with regard to the anti-inflammatory
effects of Vitamin D in Crohn*s disease.
Study design
Prospective placebo-controlled trial with Vitamin D drops 25.000 IU/week versus
placebo for 6 months in patients who have undergone ileocolonic resection for
Crohn*s disease with a primary endpoint of endoscopic recurrence as defined by
Rutgeerts* criteria.
Immediately following the surgery eligible patients will be randomized (1:1) to
postoperative treatment with Vitamin D 25.000 IU/week or placebo.
Intervention
The study subjects will receive either 25.000 IU vitamin D3 weekly or placebo,
for 26 weeks.
Study burden and risks
Excessive levels of 25(OH)D may result in hypervitaminosis D, which results in
hypercalcemia. We consider the risk of hypervitaminosis D and hypercalcemia in
this trial extremely low based on the doses of Vitamin D we will use.
Nonetheless, Vitamin D and calcium levels will be monitored throughout the
trial by an independent physician not involved in the care of the patients. The
month 6 ileocolonoscopy is currently standard of care and carries the
well-known risks of colonoscopy.
Meibergdreef 9
Amsterdam 1105 az
NL
Meibergdreef 9
Amsterdam 1105 az
NL
Listed location countries
Age
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, corrected for albumin
- 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 (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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002838-20-NL |
| CCMO | NL45391.018.13 |