Multiple Sclerosis
Conditions
Keywords
Vitamin D, Multiple Sclerosis, MRI, Randomised Trial, Finland
Brief summary
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.
Interventions
DRUGColecalciferol
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
DRUGPlacebo capsules
Identically appearing once weekly peroral placebo capsules
Sponsors
University of Turku
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Finland
Outcome results
None listed