Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
  • Phase

    Phase 2
  • Study Type

  • Status

  • Intervention/Treatment

    vitamin d3 ...
  • Study Participants

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
Study Started
Dec 31
Primary Completion
Jun 30
Study Completion
Jun 30
Last Update
Jul 29

Drug Verum arm receiving Vitamin D oil

oil: 20000 IU/g tablet: 400 IU/g every second day

Drug low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day

neutral oil and a low dose of vitamin D

Verum (high dose) Experimental

verum arm receiving high dose Vitamin D oil

Verum (low dose) Experimental

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

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
No Results Posted