Title
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
Phase
Phase 2Lead Sponsor
Humboldt UniversityStudy Type
InterventionalStatus
TerminatedIndication/Condition
Multiple SclerosisIntervention/Treatment
vitamin d3 ...Study Participants
55Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
oil: 20000 IU/g tablet: 400 IU/g every second day
neutral oil and a low dose of vitamin D
verum arm receiving high dose Vitamin D oil
low dose arm receiving neutral oil and low dose of Vitamin D
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 3 months Sufficient birth control (Pearl-Index <1) and negative pregnancy test at screening/randomization Exclusion Criteria: Any other MS-course than RRMS Treatment with high dose vitamin D within 6 months prior to randomization Patients who have received over the last three months prior to randomization, an immunomodulatory therapy with the exception of IFN-β1b (Betaferon ®) Any condition that could interfere with MRI or other study related investigation Intolerability to Gd-DTPA Hypersensitivity to the drug Colecalciferol Patients with sarcoidosis Presence or history of nephrolithiasis Pseudohypoparathyroidism Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following laboratory values: HB <8.5 g / dl WBC <2.5 / nl platelet count <100/nl Creatinine clearance by Cockcroft-Gault formula: Cl <110ml/min (male) and Cl <95ml/min (female) AST / ALT> 3.5 times higher than the upper reference value bilirubin> 2.0 mg / dl hypercalcaemia> 2.7 mmol / l calcium / creatinine ratio in urine> 1 Treatment with hydrochlorothiazide, digitoxin, digoxin, phenytoin, barbiturates Pregnancy or lactation period Participation in any clinical study within 3 months before or at any time during study 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