Inflammatory Bowel DiseasesPhase 35CNCT04991324
Cholecalciferol Comedication in IBD - the 5C-study
A Phase 3 study testing Vitamin D3 in people with Inflammatory Bowel Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2022to 15 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Crohn disease or ulcerative colitis
Who cannot join
- hypercalcaemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Vitamin D3
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called D3 VitaCaps
24,000 IU cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vitamin D3 |
| control group | No intervention | Usual treatment without vitamin D supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal calprotectin
laboratory disease activity
Measured: every 2 months during 6 months
Secondary outcomes (1)
(OH)-vitamin D serum value
serum value cholecalciferol
Measured: every 2 months during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start21 Sep 2022
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Allemann, Prof., Study chair, Pharmaceutical Care Research GroupPetr Hrúz, Prof., Principal investigator, Clarunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991324
- Sponsor's protocol ID
- 2022-00899
- Acronym
- 5C
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study
- ClinicalTrials.gov ID
- NCT04991324
- Acronym / sponsor ID
- 5C / 2022-00899
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| weekly supplementation | Experimental | Drug: Vitamin D3Weekly 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 supplementation | Active comparator | Drug: Vitamin D3Monthly 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. |
| control group | No intervention | –Usual treatment without vitamin D supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of Crohn disease or ulcerative colitis
Key exclusion criteria (1 listed)
- hypercalcaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: D3 VitaCaps24,000 IU cholecalciferol | Drug | monthly supplementation, weekly supplementation |
Primary outcome
fecal calprotectin
Time frame: every 2 months during 6 months
laboratory disease activity
1 secondary outcome
(OH)-vitamin D serum value
Time frame: every 2 months during 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Allemann, Prof. study chair
Pharmaceutical Care Research Group
Petr Hrúz, Prof. principal investigator
Clarunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 in people with Inflammatory Bowel Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal calprotectin (time frame: every 2 months during 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.