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Vitamin D and Disease Severity in Multiple SclerosisBaseline Data From the Randomized Controlled Trial (EVIDIMS)
ORIGINAL RESEARCH ARTICLE Front. Neurol., 25 February 2020
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Patients
The cohort in this study represents the baseline cohort of phase II interventional EVIDIMS trial (NCT01440062) (32) and comprised 51 patients with RRMS and 2 CIS patients, all Caucasians, according to the 2005 McDonald criteria (39). The detailed in- and exclusion criteria for the EVIDIMS trials have been published earlier (32, 38). Briefly, inclusion criteria were age of 18-65 years, Expanded Disability Status Score (EDSS) below 6.5, stable interferon-β-1b treatment for a minimum of 3 months, freedom of relapses for at least 30 days prior to study entry, and a relapsing remitting disease course or CIS. The exclusion criteria were other immunomodulatory therapies than interferon-β-1b, VD intake within 6 months before study entry, pregnancy or lactation and kidney disease, bone marrow dysfunction or hypercalcemia. To account for sunlight intensity as a possible confounder, patients were recruited from a single geographic region in the north-eastern part of Germany.
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