TY - JOUR
T1 - 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
AU - Soilu-Hänninen, Merja
AU - Åivo, Julia
AU - Lindström, Britt Marie
AU - Elovaara, Irina
AU - Sumelahti, Marja Liisa
AU - Färkkilä, Markus
AU - Tienari, Pentti
AU - Atula, Sari
AU - Sarasoja, Taneli
AU - Herrala, Lauri
AU - Keskinarkaus, Irma
AU - Kruger, Johanna
AU - Kallio, Timo
AU - Rocca, Maria A.
AU - Filippi, Massimo
PY - 2012/5
Y1 - 2012/5
N2 - 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
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 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
UR - http://www.scopus.com/inward/record.url?scp=84859612741&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84859612741&partnerID=8YFLogxK
U2 - 10.1136/jnnp-2011-301876
DO - 10.1136/jnnp-2011-301876
M3 - Article
C2 - 22362918
AN - SCOPUS:84859612741
VL - 83
SP - 565
EP - 571
JO - Journal of Neurology, Neurosurgery and Psychiatry
JF - Journal of Neurology, Neurosurgery and Psychiatry
SN - 0022-3050
IS - 5
ER -