Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: colecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RRMS EDSS 0-5 Betaferon used for at lest one month with positive MxA-response Exclusion Criteria: hypercalcaemia kidney stones uncontrolled hypertension hypothyreosis peanut allergy severe depression sarcoidosis use of other IMD than interferon-beta

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo capsules<br>Identically appearing placebo capsules not containing colecalciferol | Drug: colecalciferol<br>* 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<br>* Other names: (Dekristol®, Swiss-Caps, Switzerland);|
| Active Comparator: colecalciferol capsules<br>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 | Drug: colecalciferol<br>* 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<br>* Other names: (Dekristol®, Swiss-Caps, Switzerland);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, vitamin D, environment