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