Cholecalciferol Comedication in patients with Chronic inflammatory bowel disease (Crohn's disease or ulcerative Colitis) – the 5C-study

Objective:

The overall purpose of this study is to investigate whether the administration of vitamin D in addition to the basic treatment in IBD patients influences the intestinal inflammatory process.

Intervention:
Gelatine free soft capsules containing 24’000 IU cholecalciferol per capsule (D₃ VitaCaps^®).

• Monthly group: monthly administration of one capsule, corresponding to approximately 800 IU cholecalciferol daily.
• Weekly group: weekly administration of one capsule, corresponding to approximately 3’500 IU cholecalciferol daily.

The comparator is no cholecalciferol supplementation during study period (control group with no intervention).

Outcome:
The primary outcome will be change in the concentration of faecal calprotectin [µg/g]. Secondary outcome will be change in CRP, 25(OH)D serum levels and change in clinical disease activity scores (HBI, MTWSI).