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Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Verum arm receiving Vitamin D oil
low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH
  • Charité - Universitätsmedizin Berlin
  • Neurologische Praxis
  • Neurologisches Facharztzentrum
  • Krankenhaus Martha-Maria Halle-Dölau gGmbH
  • Sankt Josefs Krankenhaus Potsdam Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Verum (high dose)

Verum (low dose)

Arm Description

verum arm receiving high dose Vitamin D oil

low dose arm receiving neutral oil and low dose of Vitamin D

Outcomes

Primary Outcome Measures

Efficacy parameters
efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D

Secondary Outcome Measures

Safety & tolerability parameters
Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life

Full Information

First Posted
September 19, 2011
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01440062
Brief Title
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Official Title
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum (high dose)
Arm Type
Experimental
Arm Description
verum arm receiving high dose Vitamin D oil
Arm Title
Verum (low dose)
Arm Type
Experimental
Arm Description
low dose arm receiving neutral oil and low dose of Vitamin D
Intervention Type
Drug
Intervention Name(s)
Verum arm receiving Vitamin D oil
Intervention Description
oil: 20000 IU/g tablet: 400 IU/g every second day
Intervention Type
Drug
Intervention Name(s)
low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day
Intervention Description
neutral oil and a low dose of vitamin D
Primary Outcome Measure Information:
Title
Efficacy parameters
Description
efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Safety & tolerability parameters
Description
Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan-Markus Dörr, Dr.
Organizational Affiliation
Charite
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan-Markus Dörr, Dr.
Organizational Affiliation
Charite-NeuroCure
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH
City
Teupitz
State/Province
Brandenburg
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Neurologische Praxis
City
Berlin
Country
Germany
Facility Name
Neurologisches Facharztzentrum
City
Berlin
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Dölau gGmbH
City
Halle
Country
Germany
Facility Name
Sankt Josefs Krankenhaus Potsdam Neurologie
City
Potsdam
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32830462
Citation
Backer-Koduah P, Infante-Duarte C, Ivaldi F, Uccelli A, Bellmann-Strobl J, Wernecke KD, Sy M, Demetriou M, Dorr J, Paul F, Ulrich Brandt A. Effect of vitamin D supplementation on N-glycan branching and cellular immunophenotypes in MS. Ann Clin Transl Neurol. 2020 Sep;7(9):1628-1641. doi: 10.1002/acn3.51148. Epub 2020 Aug 23.
Results Reference
derived
PubMed Identifier
32047645
Citation
Dorr J, Backer-Koduah P, Wernecke KD, Becker E, Hoffmann F, Faiss J, Brockmeier B, Hoffmann O, Anvari K, Wuerfel J, Piper SK, Bellmann-Strobl J, Brandt AU, Paul F. High-dose vitamin D supplementation in multiple sclerosis - results from the randomized EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial. Mult Scler J Exp Transl Clin. 2020 Jan 24;6(1):2055217320903474. doi: 10.1177/2055217320903474. eCollection 2020 Jan-Mar.
Results Reference
derived
PubMed Identifier
22316314
Citation
Dorr 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.
Results Reference
derived

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Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

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