A randomised, double blind, placebo controlled trial with vitamin D 3 as an add on treatment to interferon β-1b in patients with multiple sclerosis

Merja Soilu-Hänninen, Julia Åivo, Britt Marie Lindström, Irina Elovaara, Marja Liisa Sumelahti, Markus Färkkilä, Pentti Tienari, Sari Atula, Taneli Sarasoja, Lauri Herrala, Irma Keskinarkaus, Johanna Kruger, Timo Kallio, Maria A. Rocca, Massimo Filippi

Research output: Contribution to journalArticlepeer-review

Abstract

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 mm 3 in the placebo group and 83 mm 3 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

Original languageEnglish
Pages (from-to)565-571
Number of pages7
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume83
Issue number5
DOIs
Publication statusPublished - May 2012

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Surgery
  • Arts and Humanities (miscellaneous)

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