Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Verum arm receiving Vitamin D oil; Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day

• Registration Number: NCT01440062
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Study Start: 2011-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum (high dose)	Verum arm receiving Vitamin D oil	verum arm receiving high dose Vitamin D oil
Verum (low dose)	low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day	low dose arm receiving neutral oil and low dose of Vitamin D

Primary Outcome Measures

Name	Time	Method
Efficacy parameters	1 day	efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D

Secondary Outcome Measures

Name	Time	Method
Safety & tolerability parameters	1 day	Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life

Trial Locations

Locations (6)

Neurologische Praxis; 🇩🇪 Berlin, Germany

Krankenhaus Martha-Maria Halle-Dölau gGmbH; 🇩🇪 Halle, Germany

Sankt Josefs Krankenhaus Potsdam Neurologie; 🇩🇪 Potsdam, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Neurologisches Facharztzentrum; 🇩🇪 Berlin, Germany

Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH; 🇩🇪 Teupitz, Brandenburg, Germany