Clinical trial NCT01440062: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2011-09-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Efficacy parameters
timeFrame: 1 day
Secondary outcomes:
measure: Safety & tolerability parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Teupitz
country: Germany
facility: Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH
state: Brandenburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Neurologische Praxis
city: Berlin
country: Germany
facility: Neurologisches Facharztzentrum
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH
city: Potsdam
country: Germany
facility: Sankt Josefs Krankenhaus Potsdam Neurologie
Study officials:
affiliation: Charite
name: Jan-Markus Dörr, Dr.
role: STUDY_DIRECTOR
affiliation: Charite-NeuroCure
name: Jan-Markus Dörr, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.