Cholecalciferol Comedication in IBD - the 5C-study

NCT04991324 | Completed Phase 3

• 1 other identifier: 2022-00899
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• fecal calprotectin

  laboratory disease activity

  every 2 months during 6 months

Secondary Outcomes (1)

• (OH)-vitamin D serum value

  every 2 months during 6 months

Other Outcomes (2)

• disease activity score

  every 2 months during 6 months

• medication adherence

  every 2 months during 6 months

Study Arms (3)

weekly supplementation

EXPERIMENTAL

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.

Drug: Vitamin D3

monthly supplementation

ACTIVE COMPARATOR

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.

Drug: Vitamin D3

control group

NO INTERVENTION

Usual treatment without vitamin D supplementation.

Interventions

Vitamin D3 DRUG

24,000 IU cholecalciferol

Also known as: D3 VitaCaps

monthly supplementation; weekly supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Crohn disease or ulcerative colitis

You may not qualify if:

• hypercalcaemia

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clarunis

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Samuel Allemann, Prof.

  Pharmaceutical Care Research Group

  STUDY CHAIR

• Petr Hrúz, Prof.

  Clarunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Patient will be recruited by their regularly visit. Patients will be randomly assigned to be supplemented with monthly capsules (monthly group), weekly capsules (weekly group) or no supplementation (control group).

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: September 21, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)