NCT01440062

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2 multiple-sclerosis

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.5 years

First QC Date

September 19, 2011

Last Update Submit

July 28, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy parameters

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

    1 day

Secondary Outcomes (1)

  • Safety & tolerability parameters

    1 day

Study Arms (2)

Verum (high dose)

EXPERIMENTAL

verum arm receiving high dose Vitamin D oil

Drug: Verum arm receiving Vitamin D oil

Verum (low dose)

EXPERIMENTAL

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

Interventions

Verum arm receiving Vitamin D oilDRUG

oil: 20000 IU/g tablet: 400 IU/g every second day

Verum (high dose)
low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second dayDRUG

neutral oil and a low dose of vitamin D

Verum (low dose)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH

Teupitz, Brandenburg, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Neurologische Praxis

Berlin, Germany

Location

Neurologisches Facharztzentrum

Berlin, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Germany

Location

Sankt Josefs Krankenhaus Potsdam Neurologie

Potsdam, Germany

Location

Related Publications (3)

  • 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.

    PMID: 32830462DERIVED

  • 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.

    PMID: 32047645DERIVED

  • 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.

    PMID: 22316314DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jan-Markus Dörr, Dr.

    Charite

    STUDY DIRECTOR

  • Jan-Markus Dörr, Dr.

    Charite-NeuroCure

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 26, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(6)