Status:
TERMINATED
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
NeuroCure Clinical Research Center, Charite, Berlin
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01440062
Start Date
December 1 2011
End Date
June 1 2017
Last Update
July 29 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH
Teupitz, Brandenburg, Germany
2
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
3
Neurologische Praxis
Berlin, Germany
4
Neurologisches Facharztzentrum
Berlin, Germany