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Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

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ClinicalTrials.gov Identifier: NCT01440062
Recruitment Status : Terminated
First Posted : September 26, 2011
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
Study Start Date : December 2011
Primary Completion Date : June 2017
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy parameters [ Time Frame: 1 day ]
    efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D


Secondary Outcome Measures :
  1. Safety & tolerability parameters [ Time Frame: 1 day ]
    Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440062


Locations
Germany
Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH
Teupitz, Brandenburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Neurologische Praxis
Berlin, Germany
Neurologisches Facharztzentrum
Berlin, Germany
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Germany
Sankt Josefs Krankenhaus Potsdam Neurologie
Potsdam, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Study Director: Jan-Markus Dörr, Dr. Charite
Principal Investigator: Jan-Markus Dörr, Dr. Charite-NeuroCure
More Information

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
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents