Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial

Jan Dorr, Stephanie Ohlraun, Horst Skarabis and Friedemann Paul
Trials 2012, 13:15 doi:10.1186/1745-6215-13-15
Published: 8 February 2012

Background: Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults.
Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse.
We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects.

Methods: The EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study.
Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-beta1b will be randomized to additionally receive either high-dose (average daily dose 10,200 IU) or low-dose (average daily dose 200 IU) cholecalciferol for a total period of 18 months.
The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla.
Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters.

Discussion: In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation of the efficacy of high-dose vitamin D supplementation in MS patients. The study design presented here fulfills the criteria of a high-quality clinical phase II trial in MS. Trial Registration: www.ClinicalTrials.gov Identifier: NCT01440062

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See also Vitamin D Life

• Overview MS and Vitamin D - includes the following item
  • MS 20X more correlated to UV than other variables – Jan 2011 controversy
• MS Clinical trial using up to 10,000 IU of vitamin D – Feb 2012 another MS RCT - in Australia
• 10,000 IU vitamin D plus 1200 mg Calcium MS trial April 2010 - investigate if get too much Calcium, noticed that it reduced MS relapses
• Yet again - more than 10,000 IU of vitamin D treats MS – July 2011
• 20,000 IU vitamin D and MS – less fatigue and relapse Dec 2010
• 300,000 IU vitamin D monthly may treat MS – May 2011 injection averaged to 10,000 IU daily
• All items in MS and Vitamin D 356 items
• Vitamin D for MS is becoming mainstream Blog post at Vitamin D Life Feb 2012