RT Journal Article SR Electronic T1 A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon β-1b in patients with multiple sclerosis JF Journal of Neurology, Neurosurgery & Psychiatry JO J Neurol Neurosurg Psychiatry FD BMJ Publishing Group Ltd SP 565 OP 571 DO 10.1136/jnnp-2011-301876 VO 83 IS 5 A1 Soilu-Hänninen, Merja A1 Åivo, Julia A1 Lindström, Britt-Marie A1 Elovaara, Irina A1 Sumelahti, Marja-Liisa A1 Färkkilä, Markus A1 Tienari, Pentti A1 Atula, Sari A1 Sarasoja, Taneli A1 Herrala, Lauri A1 Keskinarkaus, Irma A1 Kruger, Johanna A1 Kallio, Timo A1 Rocca, Maria A A1 Filippi, Massimo YR 2012 UL http://jnnp.bmj.com/content/83/5/565.abstract AB Objectives To study the safety and efficacy of vitamin D3 as an add on therapy to interferon β-1b (IFNB) in patients with multiple sclerosis (MS).Methods 1 year, double blind, placebo controlled, randomised study in 66 MS patients. The primary outcomes were T2 burden of disease (BOD) on MRI scans, proportion of patients with serum levels of 25-hydroxyvitamin D (25(OH)D) ≥85 nmol/l or intact parathyroid hormone (PTH) ≤20 ng/l, and number of adverse events. Secondary outcomes were number of MRI enhancing T1 lesions and new T2 lesions, annual relapse rate, changes in the Expanded Disability Status Scale score, timed 25 foot walk test and timed 10 foot tandem walk tests.Results Median change in BOD was 287 mm3 in the placebo group and 83 mm3 in the vitamin D group (p=0.105). Serum levels of 25(OH)D increased from a mean of 54 (range 19–82) nmol/l to 110 (range 67–163) nmol/l in the vitamin D group. 84% of patients reached a serum 25(OH)D level >85 nmol/l in the vitamin D group and 3% in the placebo group (p<0.0001). Patients in the vitamin D group showed fewer new T2 lesions (p=0.286) and a significantly lower number of T1 enhancing lesions (p=0.004), as well as a tendency to reduced disability accumulation (p=0.071) and to improved timed tandem walk (p=0.076). There were no significant differences in adverse events or in the annual relapse rate.Conclusion Vitamin D3 add on treatment to IFNB reduces MRI disease activity in MS.Trial registration number EudraCT number 2007-001958-99 and ClinicalTrialsGov number NCT01339676.