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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 : April 15, 2020
Sponsor:
Collaborator:
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE September 19, 2011
First Posted Date  ICMJE September 26, 2011
Last Update Posted Date April 15, 2020
Study Start Date  ICMJE December 2011
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2011)
Efficacy parameters [ Time Frame: 1 day ]
efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
Efficacy parameters [ Time Frame: 1 day ]
efficacy of Vitamin D in patients with Multiple Sclerosis compared to placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
Safety & tolerability parameters [ Time Frame: 1 day ]
Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Official Title  ICMJE Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
Brief Summary Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)
55
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2011)
80
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01440062
Other Study ID Numbers  ICMJE EVIDIMS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan-Markus Dörr, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE NeuroCure Clinical Research Center, Charite, Berlin
Investigators  ICMJE
Study Director: Jan-Markus Dörr, Dr. Charite
Principal Investigator: Jan-Markus Dörr, Dr. Charite-NeuroCure
PRS Account Charite University, Berlin, Germany
Verification Date April 2020

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