Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
This study is currently recruiting participants.
Verified February 2013 by Charite University, Berlin, Germany
Sponsor:
Charite University, Berlin, Germany
Collaborator:
NeuroCure
Information provided by (Responsible Party):
Jan-Markus Dörr, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01440062
First received: September 19, 2011
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Verum arm receiving Vitamin D oil Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
Drug Information available for:
Vitamin D
U.S. FDA Resources
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Efficacy parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D
Secondary Outcome Measures:
- Safety & tolerability parameters [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Verum (high dose)
verum arm receiving high dose Vitamin D oil
|
Drug: Verum arm receiving Vitamin D oil
oil: 20000 IU/g tablet: 400 IU/g every second day
|
|
Experimental: Verum (low dose)
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
neutral oil and a low dose of vitamin D
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 sacoridosis
- Presence or history of nephrolithiasis
- Pseudohypoparathyroidism
Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following labratory values:
- HB <8.5 g / dl
- WBC <2.5 / nl
- platelet count <100/nl
- Creatinine clearance by Cockroft-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 hydrochlorthiazide, 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440062
Contacts
| Contact: Jan-Markus Dörr, Dr. | 030-450660162 | jan-markus.doerr@charite.de |
Locations
| Germany | |
| Charité - Universitätsmedizin Berlin | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: Jan-Markus Dörr, Dr. 030-450660162 jan-markus.dörr@charite.de | |
| Principal Investigator: Jan-Markus Dörr, Dr. | |
| Neurologische Praxis | Recruiting |
| Berlin, Germany | |
| Contact: Kerstin Anvari, MD | |
| Neurologisches Facharztzentrum | Recruiting |
| Berlin, Germany | |
| Contact: Elke Becker, MD | |
| Neurologische Praxis | Recruiting |
| Berlin, Germany | |
| Contact: Bernd Brockmeier, MD | |
| Krankenhaus Martha-Maria Halle-Dölau gGmbH | Recruiting |
| Halle, Germany | |
| Contact: Frank A. Hoffmann, MD | |
| Ruppiner Kliniken GmbH Neurologie | Recruiting |
| Neuruppin, Germany | |
| Contact: Andreas Bitsch, MD | |
| Sankt Josefs Krankenhaus Potsdam Neurologie | Recruiting |
| Potsdam, Germany | |
| Contact: Olaf Hoffmann, MD | |
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure
Investigators
| Study Director: | Jan-Markus Dörr, Dr. | Charite |
| Principal Investigator: | Jan-Markus Dörr, Dr. | Charite-NeuroCure |
More Information
No publications provided by Charite University, Berlin, Germany
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jan-Markus Dörr, MD, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01440062 History of Changes |
| Other Study ID Numbers: | EVIDIMS |
| Study First Received: | September 19, 2011 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013