Multiple SclerosisPhase 2/3100207MS-HNCT01432704
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
A Phase 2/3 study testing colecalciferol in people with Multiple Sclerosis, run by University of Turku.
Trial summary
This is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b for Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- colecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Aug 2011
- Phase
- Phase 2/3
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- RRMS EDSS 0-5
- Betaferon used for at lest one month with positive MxA-response
Who cannot join
- hypercalcaemia
- kidney stones
- uncontrolled hypertension
- hypothyreosis
- peanut allergy
- severe depression
- sarcoidosis
- use of other IMD than interferon-beta
About this study
Official title: Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
This is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin D suppresses clinical and MRI activity of MS.
Read the detailed description
The patients will be examined clinically at baseline and at 6, and 12 months. Laboratory assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline. MRI will be performed (T1-weighted and T2-weighted) at randomization and 12 months thereafter. Sample size is 80 patients: two groups with 40 patients in each group. The primary statistical analyses will be based on the intent-to-treat (ITT) population which consist of all randomized patients who have started study medication. The primary efficacy variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate. The incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate and severe), laboratory abnormalities, dose adjustments, and significant adverse events will be calculated. The vitamin D status (proportion of patients with P-PTH <20 ng/l and S-OH(D)2 >85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.
- Conditions
- Multiple Sclerosis
- Being tested
- colecalciferol
- Keywords
- MS, vitamin D, environment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colecalciferolDrug
Also called (Dekristol®, Swiss-Caps, Switzerland)
Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
| Study group | Role | What they receive |
|---|---|---|
| placebo capsules | Placebo comparator | Identically appearing placebo capsules not containing colecalciferol Receives: Drug: colecalciferol |
| colecalciferol capsules | Active comparator | Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months Receives: Drug: colecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: one year
To estimate the effect of interferon-beta-1b with an add-on of colecalciferol versus interferon-beta-1b with an add-on of placebo on MRI T2 BOD at 12 months in comparison with MRI T2 BOD at baseline
Measured: 12 months
Secondary outcomes (1)
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startMar 2008
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Merja Soilu-Hänninen, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432704
- Sponsor's protocol ID
- EudraCT 2007-001958-99
- Acronym
- 100207MS-H
- Status last verified
- Sep 2011
- First submitted
- 16 Aug 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
- ClinicalTrials.gov ID
- NCT01432704
- Acronym / sponsor ID
- 100207MS-H / EudraCT 2007-001958-99
- Conditions
- Multiple Sclerosis
- Keywords
- MS, vitamin D, environment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Sep 2011 (estimated)
- 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.
This is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin D suppresses clinical and MRI activity of MS.
Detailed description
The patients will be examined clinically at baseline and at 6, and 12 months. Laboratory assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline. MRI will be performed (T1-weighted and T2-weighted) at randomization and 12 months thereafter. Sample size is 80 patients: two groups with 40 patients in each group. The primary statistical analyses will be based on the intent-to-treat (ITT) population which consist of all randomized patients who have started study medication. The primary efficacy variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate. The incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate and severe), laboratory abnormalities, dose adjustments, and significant adverse events will be calculated. The vitamin D status (proportion of patients with P-PTH <20 ng/l and S-OH(D)2 >85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo capsules | Placebo comparator | Drug: colecalciferolIdentically appearing placebo capsules not containing colecalciferol |
| colecalciferol capsules | Active comparator | Drug: colecalciferolOnce weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- RRMS EDSS 0-5
- Betaferon used for at lest one month with positive MxA-response
Key exclusion criteria (8 listed)
- hypercalcaemia
- kidney stones
- uncontrolled hypertension
- hypothyreosis
- peanut allergy
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 |
|---|---|---|
| colecalciferolAlso: (Dekristol®, Swiss-Caps, Switzerland)Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months | Drug | colecalciferol capsules, placebo capsules |
Primary outcome
To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and
Time frame: one year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To estimate the effect of interferon-beta-1b with an add-on of colecalciferol versus interferon-beta-1b with an add-on of placebo on MRI T2 BOD at 12 months in comparison with MRI T2 BOD at baseline
Time frame: 12 months
1 secondary outcome
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
Time frame: 12 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 13 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing colecalciferol in people with Multiple Sclerosis, run by University of Turku.
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 2 inclusion and 8 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 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and (time frame: one year). The study lists 2 primary outcomes in all. 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 13 Sep 2011.