A randomised, double blind, placebo controlled trial with vitamin D3as an add on treatment to interferon β-1b in patients with multiple sclerosis
| Autor: | Timo Kallio, Massimo Filippi, Johanna Krüger, Julia Åivo, Merja Soilu-Hänninen, Irma Keskinarkaus, Taneli Sarasoja, Lauri Herrala, Sari Atula, Irina Elovaara, Britt Marie Lindström, Marja Liisa Sumelahti, Maria A. Rocca, Markus Färkkilä, Pentti J. Tienari |
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| Rok vydání: | 2012 |
| Předmět: |
Vitamin
medicine.medical_specialty Placebo-controlled study Placebo Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Vitamin D and neurology medicine 10. No inequality Adverse effect 030304 developmental biology 0303 health sciences Expanded Disability Status Scale business.industry Multiple sclerosis Interferon beta-1b medicine.disease 3. Good health Surgery Psychiatry and Mental health chemistry Neurology (clinical) business 030217 neurology & neurosurgery |
| Zdroj: | Journal of Neurology, Neurosurgery & Psychiatry. 83:565-571 |
| ISSN: | 1468-330X 0022-3050 |
| Popis: | 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 Conclusion Vitamin D3 add on treatment to IFNB reduces MRI disease activity in MS. Trial registration number EudraCT number 2007-001958-99 and ClinicalTrialsGov number NCT01339676. |
| Databáze: | OpenAIRE |
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