Cholecalciferol in Chronic Inflammatory Bowel Diseases

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In our research project, we want to find out whether the additional intake of vitamin D further reduces the inflammatory events in the intestines of IBD patients. There are three groups of subjects: the 1st group takes a capsule of 24,000 IU per week, the 2nd group takes 24,000 IU per month, the 3rd group is the control group. The intake extends over 6 months during the autumn and winter period.

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

Details

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

Criteria

Inclusion Criteria:

• Confirmed IBD diagnosis; Age ≥ 18 years

Exclusion Criteria:

• Hypercalcaemia defined as serum calcium value >2.70 mmol/l; Hyperparathyreoidism defined as serum iPTH value >65 ng/l; Hypoparathyreoidism defined as serum iPTH value <15 ng/l; Renal insufficiency defined as eGFR < 30 ml/min; Anamnesis of: Propensity to form calcium-containing kidney stones, Impaired renal calcium or phosphate excretion, Sarcoidosis; Pregnancy or lactation; Supplementation of vitamin D >200 IU/d (5μg/d) during study period; Administration of products that have a potential interaction with cholecalciferol, e.g. phenytoin, rifampicin, barbiturates, actinomycin, imidazole-antifungals