The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins