Back to results

Cholecalciferol Comedication in IBD - the 5C-study (5C)

Primary Purpose

Inflammatory Bowel Diseases

Status

Recruiting

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria:

hypercalcaemia

Sites / Locations

ClarunisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

weekly supplementation

monthly supplementation

control group

Arm 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.

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.

Usual treatment without vitamin D supplementation.

Outcomes

Primary Outcome Measures

fecal calprotectin

laboratory disease activity

Secondary Outcome Measures

(OH)-vitamin D serum value

serum value cholecalciferol

Full Information

NCT ID

NCT04991324

First Posted

July 27, 2021

Last Updated

May 8, 2023

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04991324

Brief Title

Cholecalciferol Comedication in IBD - the 5C-study

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 21, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

weekly supplementation

Arm Type

Experimental

Arm 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.

Arm Title

monthly supplementation

Arm Type

Active Comparator

Arm 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.

Arm Title

control group

Arm Type

No Intervention

Arm Description

Usual treatment without vitamin D supplementation.

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

D3 VitaCaps

Intervention Description

24,000 IU cholecalciferol

Primary Outcome Measure Information:

Title

fecal calprotectin

Description

laboratory disease activity

Time Frame

every 2 months during 6 months

Secondary Outcome Measure Information:

Title

(OH)-vitamin D serum value

Description

serum value cholecalciferol

Time Frame

every 2 months during 6 months

Other Pre-specified Outcome Measures:

Title

disease activity score

Description

clinical disease activity

Time Frame

every 2 months during 6 months

Title

medication adherence

Description

adherence to vitamin D supplementation

Time Frame

every 2 months during 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of Crohn disease or ulcerative colitis Exclusion Criteria: hypercalcaemia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Pierre Rothen, PhD

Phone

+41 61 207 15 67

jp.rothen@unibas.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Petr Hrúz, Prof.

Phone

+41 61 777 75 75

petr.hruz@clarunis.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Allemann, Prof.

Organizational Affiliation

Pharmaceutical Care Research Group

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Petr Hrúz, Prof.

Organizational Affiliation

Clarunis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clarunis

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cholecalciferol Comedication in IBD - the 5C-study

We'll reach out to this number within 24 hrs