Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Multiple Sclerosis Clinical Trial

Official title:

Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01440062
• Other study ID #: EVIDIMS
• Status: Terminated
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: June 2017

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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-ß1b (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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Verum arm receiving Vitamin D oil
oil: 20000 IU/g tablet: 400 IU/g every second day
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy parameters	efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D	1 day
Secondary	Safety & tolerability parameters	Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life	1 day