Cholecalciferol Comedication in IBD - the 5C-study

Phase 3

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Vitamin D3

• Registration Number: NCT04991324
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Monthly supplementation: Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.

Weekly supplementation: Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.

Control: Usual treatment without vitamin D supplementation. All 3 groups: In a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin D supplementation or not.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Study Start: 2022-09-21
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria

• hypercalcaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
weekly supplementation	Vitamin D3	Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.
monthly supplementation	Vitamin D3	Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.

Primary Outcome Measures

Name	Time	Method
fecal calprotectin	every 2 months during 6 months	laboratory disease activity

Secondary Outcome Measures

Name	Time	Method
(OH)-vitamin D serum value	every 2 months during 6 months	serum value cholecalciferol

Trial Locations

Locations (1)

Clarunis; 🇨🇭 Basel, Switzerland