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 journalArticle

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

Fingerprint

Cholecalciferol
Interferons
Multiple Sclerosis
Placebos
Serum
Therapeutics
Parathyroid Hormone
Vitamin D
Magnetic Resonance Imaging
Safety
Recurrence
Placebo
Controlled
Walk Test
Lesion
Burden

ASJC Scopus subject areas

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

Cite this

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 journalArticle

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.
@article{998c9f0cc47f4546a72f1cc52c002e2b,
title = "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",
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",
author = "Merja Soilu-H{\"a}nninen and Julia {\AA}ivo and Lindstr{\"o}m, {Britt Marie} and Irina Elovaara and Sumelahti, {Marja Liisa} and Markus F{\"a}rkkil{\"a} and Pentti Tienari and Sari Atula and Taneli Sarasoja and Lauri Herrala and Irma Keskinarkaus and Johanna Kruger and Timo Kallio and Rocca, {Maria A.} and Massimo Filippi",
year = "2012",
month = "5",
doi = "10.1136/jnnp-2011-301876",
language = "English",
volume = "83",
pages = "565--571",
journal = "Journal of Neurology, Neurosurgery and Psychiatry",
issn = "0022-3050",
publisher = "BMJ Publishing Group",
number = "5",

}

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 -