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Cholecalciferol Comedication in IBD - the 5C-study

NCT ID: NCT04991324

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2024-09-15

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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weekly supplementation

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.

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

24,000 IU cholecalciferol

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.

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

24,000 IU cholecalciferol

control group

Usual treatment without vitamin D supplementation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D3

24,000 IU cholecalciferol

Intervention Type DRUG

Other Intervention Names

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D3 VitaCaps

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria

* hypercalcaemia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Allemann, Prof.

Role: STUDY_CHAIR

Pharmaceutical Care Research Group

Petr Hrúz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Clarunis

Locations

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Clarunis

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-00899

Identifier Type: -

Identifier Source: org_study_id

NCT05624801

Identifier Type: -

Identifier Source: nct_alias