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

doi:10.1136/jnnp-2011-301876

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

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	565-571
Number of pages	7
Journal	Journal of Neurology, Neurosurgery and Psychiatry
Volume	83
Issue number	5
DOIs	https://doi.org/10.1136/jnnp-2011-301876
Publication status	Published - May 2012

ASJC Scopus subject areas

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

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Soilu-Hänninen, M., Åivo, J., Lindström, B. M., Elovaara, I., Sumelahti, M. L., Färkkilä, M., Tienari, P., Atula, S., Sarasoja, T., Herrala, L., Keskinarkaus, I., Kruger, J., Kallio, T., Rocca, M. A., & Filippi, M. (2012). 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. Journal of Neurology, Neurosurgery and Psychiatry, 83(5), 565-571. https://doi.org/10.1136/jnnp-2011-301876

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

In: Journal of Neurology, Neurosurgery and Psychiatry, Vol. 83, No. 5, 05.2012, p. 565-571.

Research output: Contribution to journal › Article › peer-review

Soilu-Hänninen, M, Åivo, J, Lindström, BM, Elovaara, I, Sumelahti, ML, Färkkilä, M, Tienari, P, Atula, S, Sarasoja, T, Herrala, L, Keskinarkaus, I, Kruger, J, Kallio, T, Rocca, MA & Filippi, M 2012, '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', Journal of Neurology, Neurosurgery and Psychiatry, vol. 83, no. 5, pp. 565-571. https://doi.org/10.1136/jnnp-2011-301876

Soilu-Hänninen, Merja ; Åivo, Julia ; Lindström, Britt Marie ; Elovaara, Irina ; Sumelahti, Marja Liisa ; Färkkilä, Markus ; Tienari, Pentti ; Atula, Sari ; Sarasoja, Taneli ; Herrala, Lauri ; Keskinarkaus, Irma ; Kruger, Johanna ; Kallio, Timo ; Rocca, Maria A. ; Filippi, Massimo. / 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. In: Journal of Neurology, Neurosurgery and Psychiatry. 2012 ; Vol. 83, No. 5. pp. 565-571.

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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",

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AU - Elovaara, Irina

AU - Sumelahti, Marja Liisa

AU - Färkkilä, Markus

AU - Tienari, Pentti

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AU - Sarasoja, Taneli

AU - Herrala, Lauri

AU - Keskinarkaus, Irma

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