Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 17, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Verum arm receiving Vitamin D oil
Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Safety & tolerability parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum (high dose)
verum arm receiving high dose Vitamin D oil
Drug: Verum arm receiving Vitamin D oil
oil: 20000 IU/g tablet: 400 IU/g every second day
Experimental: Verum (low dose)
low dose arm receiving neutral oil and low dose of Vitamin D
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440062

Contacts
Contact: Jan-Markus Dörr, Dr. 030-450660162 jan-markus.doerr@charite.de

Locations
Germany
Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH Recruiting
Teupitz, Brandenburg, Germany
Contact: Jürgen Faiss, Prof. Dr.         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Jan-Markus Dörr, Dr.    030-450660162    jan-markus.dörr@charite.de   
Principal Investigator: Jan-Markus Dörr, Dr.         
Neurologische Praxis Recruiting
Berlin, Germany
Contact: Kerstin Anvari, MD         
Neurologisches Facharztzentrum Recruiting
Berlin, Germany
Contact: Elke Becker, MD         
Neurologische Praxis Recruiting
Berlin, Germany
Contact: Bernd Brockmeier, MD         
Krankenhaus Martha-Maria Halle-Dölau gGmbH Recruiting
Halle, Germany
Contact: Frank A. Hoffmann, MD         
Sankt Josefs Krankenhaus Potsdam Neurologie Recruiting
Potsdam, Germany
Contact: Olaf Hoffmann, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Charité Neurocure AG Flöel
Investigators
Study Director: Jan-Markus Dörr, Dr. Charite
Principal Investigator: Jan-Markus Dörr, Dr. Charite-NeuroCure
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan-Markus Dörr, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01440062     History of Changes
Other Study ID Numbers: EVIDIMS
Study First Received: September 19, 2011
Last Updated: September 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014