Multiple Sclerosis and Clinical isolated Syndrome
Conditions
Interventions
Trade Name: Vigantol® Öl 20.000 I.E./ml
Product Name: Vigantol® Öl 20.000 I.E./ml
Product Code: Vigantol® Öl 20.000 I.E./ml
Pharmaceutical Form: Oral liquid
INN or Proposed INN: COLECALCIFEROL
CAS Num
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent Age between 18 and 65 at randomization Relapsing-remitting MS according to the revised McDonald-Criteria (2005) EDSS = 6,0 Stable immunomodulatory treatment for at least 6 months Sufficient birth control (Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: Any other MS-course than RRMS Treatment with vitamin D within three months prior to randomization Any condition that could interfere with MRI or other study related investigation Intolerability of Gd-DTPA Hypercalcaemia and/or hypercalcuria Presence or history of nephrolithiasis Clinically relevant dysfunction of kidney (creatinine-clearance (Cockroft-Gault) Cl < 110ml/min (male) or Cl < 95ml/min (female) Clinically relevant gastrointestinal, hepatological, pulmonary, cardiological, hematological, infectious or CNS-disease (other than MS) disease Allergy against components of study drug Treatment with hydrochlorthiazide, digitoxin, digoxin, phenytoin, barbiturates Clinically relevant drug- or alcohol abuse Pregnancy or lactation period Participation in any clinical study within 3 months before or at any time during study Treatment within 6 months before randomization with any other immunomodulatory substance than IFN-ß, glatiramer acetate or intravenous methylprednisolone Any medical, psychiatric or other condition that could interfere with the patient’s ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of Vitamin D supplementation in relapsing-remitting Multiple Sclerosis ;Secondary Objective: To assess safety and compatibility of Vitamin D supplementation in relapsing-remitting Multiple Sclerosis To compare secondary endpoints between the verum and placebo group ;Primary end point(s): Cumulative number of new hyperintense lesions in T2-weighted cranial MR imaging ;Timepoint(s) of evaluation of this end point: after 18 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Annualized relapse rate, proportion of relapse-free patients, disease progression, percentage of patients without disease activity, proportion of patients with a conversion into a definitive MS (only in CIS patients), other MRI parameters (number / volume of new hypointense T1 lesions, brain atrophy, number of lesions absorbing contrast agent, spectroscopy) cognition, fatigue, depression, Retinal nerve fiber layer thickness and macular volume, visual contrast sensitivity, 25OH vitamin D serum levels, quality of life, immunological parameters ;Timepoint(s) of evaluation of this end point: after 18 months treatment | — |
Countries
Germany
Contacts
Public ContactPI
Charité - Universitätsmedizin Berlin
Outcome results
None listed