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

Study Overview
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Brief Summary
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This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.

Official Title
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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
* Drug: Placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 55 years remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month EDSS (expanded disability statsu scale) ≤ 5 no neutralising antibodies to INFB as measured by indirect MxA test prepared and considered to follow the protocol using appropriate contraceptive methods (women of childbearing potential) has given informed consent Exclusion Criteria: serum calcium >2.6 mmol/L serum 25(OH)D2 (kalsidiol) > 85 nmol/L presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L) pregnancy or unwillingness to use contraception alcohol or drug abuse use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses current use of other immunomodulatory therapy than interferon-beta-1b known allergy to cholecalciferol or arachis oil (peanuts) therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry any condition predisposing to hypercalcaemia (such as any type of cancer) sarcoidosis nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit significant hypertension (Blood Pressure <180/110 mmHg) hyperthyroidism, or hypothyroidism in the year before the study began a history of nephrolithiasis during the previous five years cardiac insufficiency or significant cardiac dysrhythmia unstable or advanced ischaemic heart disease has suffered a major depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: 1<br>Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D | Drug: Colecalciferol<br>* Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D<br>* Other names: Vitamin D;|
| Placebo Comparator: 2<br>Identically appearing once weekly peroral capsules | Drug: Placebo capsules<br>* Identically appearing once weekly peroral placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland