(25-10-14) A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon b-1b in patients with mult

Merja Soilu-Ha ̈nninen,1 Julia A ̊ivo,1 Britt-Marie Lindstro ̈m,2 Irina Elovaara,3Marja-Liisa Sumelahti,3 Markus Fa ̈rkkila ̈,Lauri Herrala,6 Irma Keskinarkaus,7 Johanna Kruger,7 Timo Kallio,8Maria A Rocca,9 Massimo Filippi9

ABSTRACT

Objectives To study the safety and efficacy of vitaminD3 as an add on therapy to interferon b-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 theplacebo group and 83 mm3 in the vitamin D group
(p1⁄40.105). Serum levels of 25(OH)D increased froma mean of 54 (range 19e82) nmol/l to 110 (range
67e163) 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 (p1⁄40.286) and a significantly lower number of T1 enhancing lesions (p1⁄40.004), as
well as a tendency to reduced disability accumulation (p1⁄40.071) and to improved timed tandem walk
(p1⁄40.076). 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 ClinicalTrials Gov number NCT01339676.

Source: J Neurol Neurosurg Psychiatry. 2012;83(5):565-571.

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