Cholecalciferol Comedication in IBD - the 5C Study

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria:

• hypercalcaemia