Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Charité Neurocure AG Flöel
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01440062
First received: September 19, 2011
Last updated: January 8, 2014
Last verified: January 2014

September 19, 2011
January 8, 2014
December 2011
December 2016   (final data collection date for primary outcome measure)
Efficacy parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D
Efficacy parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
efficacy of Vitamin D in patients with Multiple Sclerosis compared to placebo
Complete list of historical versions of study NCT01440062 on ClinicalTrials.gov Archive Site
Safety & tolerability parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life
Same as current
Not Provided
Not Provided
 
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • 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
  • Experimental: Verum (high dose)
    verum arm receiving high dose Vitamin D oil
    Intervention: Drug: Verum arm receiving Vitamin D oil
  • Experimental: Verum (low dose)
    low dose arm receiving neutral oil and low dose of Vitamin D
    Intervention: Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day
Dörr J, Ohlraun S, Skarabis H, Paul F. Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial. Trials. 2012 Feb 8;13:15. doi: 10.1186/1745-6215-13-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Jan-Markus Dörr, Dr. 030-450660162 jan-markus.doerr@charite.de
Germany
 
NCT01440062
EVIDIMS
No
Jan-Markus Dörr, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Charité Neurocure AG Flöel
Study Director: Jan-Markus Dörr, Dr. Charite
Principal Investigator: Jan-Markus Dörr, Dr. Charite-NeuroCure
Charite University, Berlin, Germany
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP