Cholecalciferol Comedication in IBD - the 5C-study

University Hospital Basel

Status and phase: Completed; Phase 3

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT04991324

2022-00899

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of Crohn disease or ulcerative colitis

Exclusion criteria

• hypercalcaemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

weekly supplementation

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D3

monthly supplementation

Active Comparator group

Description:

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.

Treatment:

Drug: Vitamin D3

control group

No Intervention group

Description:

Usual treatment without vitamin D supplementation.