EVIDIMS: Vitamin D in multiple sclerosis

Study Description:
In this study, we investigated whether the regular high-dose intake of vitamin D positively impacts the clinical course and various MRI parameters in patients with relapsing-remitting MS or even clinically isolated syndrom. A number of studies suggest that the blood level of vitamin D can influence both the disease risk and course of MS. However, it is unclear whether this also applies to the intake of vitamin D. A unique feature of this study was that, in contrast to the more frequent placebo-controlled trials, two different dosages of vitamin D are compared. This means that all study participants received vitamin D. Participation was open to male and female patients who have received MS treatment with interferon-β1b for at least the last three months. The study drug was taken orally every two days over a period of 1.5 years and was very well tolerated. Treatment with interferon-β1b was continued during the study. Patients were seen and examined regularly in the study outpatient clinic.

Principle Investigators: Dr. Jan Dörr (Clinical Neuroimmunology, NCRC)

Registration: This study is registered in the database clinicaltrials.gov (NCT01440062).

Course of the study: 01/2012 - 06/2017

Publications:
Backer-Koduah, P., J. Bellmann-Strobl, M. Scheel, J. Wuerfel, K. D. Wernecke, J. Dorr, A. U. Brandt, and F. Paul. "Vitamin D and Disease Severity in Multiple Sclerosis-Baseline Data from the Randomized Controlled Trial (Evidims)." Frontiers in Neurology 11 (Feb 25 2020). Link.

Backer-Koduah, P., C. Infante-Duarte, F. Ivaldi, A. Uccelli, J. Bellmann-Strobl, K. D. Wernecke, M. Sy, M. Demetriou, J. Dorr, F. Paul, and A. U. Brandt. "Effect of Vitamin D Supplementation on N-Glycan Branching and Cellular Immunophenotypes in Ms." Annals of Clinical and Translational Neurology 7, no. 9 (Sep 2020): 1628-41. Link.

Dorr, J., P. Backer-Koduah, K. D. Wernecke, E. Becker, F. Hoffmann, J. Faiss, B. Brockmeier, O. Hoffmann, K. Anvari, J. Wuerfel, S. K. Piper, J. Bellmann-Strobl, A. U. Brandt, and F. Paul. "High-Dose Vitamin D Supplementation in Multiple Sclerosis - Results from the Randomized Evidims (Efficacy of Vitamin D Supplementation in Multiple Sclerosis) Trial." Mult Scler J Exp Transl Clin 6, no. 1 (Jan-Mar 2020): 2055217320903474. Link.

Dorr, J., S. Ohlraun, H. Skarabis, and F. Paul. "Efficacy of Vitamin D Supplementation in Multiple Sclerosis (Evidims Trial): Study Protocol for a Randomized Controlled Trial." Trials 13 (Feb 08 2012): 15. http://dx.doi.org/10.1186/1745-6215-13-15. Link.