Cholecalciferol Comedication in IBD - the 5C-study

Inflammatory Bowel Diseases Clinical Trial

— 5C  

Official title:

Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991324
• Other study ID #: 2022-00899
• Status: Recruiting
• Phase: Phase 3
• Start date: September 21, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Jean-Pierre Rothen, PhD
• Phone: +41 61 207 15 67
• Email: jp.rothen[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT05624801

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria:

• hypercalcaemia

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Vitamin D3
24,000 IU cholecalciferol

Locations

Country	Name	City	State
Switzerland	Clarunis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	disease activity score	clinical disease activity	every 2 months during 6 months
Other	medication adherence	adherence to vitamin D supplementation	every 2 months during 6 months
Primary	fecal calprotectin	laboratory disease activity	every 2 months during 6 months
Secondary	(OH)-vitamin D serum value	serum value cholecalciferol	every 2 months during 6 months