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

Volumn 83, Issue 5, 2012, Pages 565-571

  Soilu Hänninen, Merja ^a   Åivo, Julia ^a   Lindström, Britt Marie ^b   Elovaara, Irina ^c   Sumelahti, Marja Liisa ^c   Färkkilä, Markus ^d   Tienari, Pentti ^d   Atula, Sari ^d   Sarasoja, Taneli ^e   Herrala, Lauri ^f   Keskinarkaus, Irma ^g   Kruger, Johanna ^g   Kallio, Timo ^h   Rocca, Maria A ⁱ   Filippi, Massimo ⁱ  

^a UNIVERSITY OF TURKU   (Finland)

^b 4Pharma Ltd   (Finland)

^c TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

^d UNIVERSITY OF HELSINKI   (Finland)

^e JYVÄSKYLÄ CENTRAL HOSPITAL   (Finland)

^f Central Hospital of Ostrobotnia   (Finland)

^g UNIVERSITY OF OULU   (Finland)

^h Terveystalo Clinical Research   (Finland)

ⁱ VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

25 HYDROXYVITAMIN D; ANTIBIOTIC AGENT; COLECALCIFEROL; ERGOCALCIFEROL; GADOLINIUM; INTERFERON BETA SERINE; PARATHYROID HORMONE;

ADD ON THERAPY; ADULT; ARTICLE; CONTRAST ENHANCEMENT; CONTROLLED STUDY; DIARRHEA; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; ERYSIPELAS; EXERCISE TEST; EXPANDED DISABILITY STATUS SCALE; FEMALE; HUMAN; HYPERCALCEMIA; MAJOR CLINICAL STUDY; MALE; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PARATHYROID HORMONE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; TREATMENT DURATION; VITAMIN BLOOD LEVEL; WALKING;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; BRAIN; CHOLECALCIFEROL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERFERON-BETA; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; NEUROIMAGING; PARATHYROID HORMONE; RECURRENCE; SEVERITY OF ILLNESS INDEX; VITAMIN D; VITAMINS; WALKING;

EID: 84859612741     PISSN: 00223050     EISSN: 1468330X     Source Type: Journal    
DOI: 10.1136/jnnp-2011-301876     Document Type: Article

References (33)

1. Sumelahti ML, Tienari PJ, Hakama M, et al. Multiple sclerosis in Finland: incidence trends and differences in relapsing remitting and primary progressive disease courses. J Neurol Neurosurg Psychiatry 2003;74:25-8. (Pubitemid 36069031)
2. Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc 2000;59:531-5. (Pubitemid 32002983)
3. Simpson S Jr, Blizzard L, Otahal P, et al. Latitude is significantly associated with the prevalence of multiple sclerosis: a meta-analysis. J Neurol Neurosurg Psychiatry 2011;82:1132-41.
4. Soilu-Hanninen M, Airas L, Mononen I, et al. 25-Hydroxyvitamin D levels in serum at the onset of multiple sclerosis. Mult Scler 2005;11:266-71. (Pubitemid 40775180)
5. Saastamoinen KP, Auvinen MK, Tienari PJ. Month of birth is associated with multiple sclerosis but not with HLA-DR15 in Finland. Mult Scler. Published Online First: 31 October 2011. doi:10.1177/1352458511426814.
6. Mirzaei F, Michels KB, Munger K, et al. Gestational vitamin D and the risk of MS in the offspring. Ann Neurol 2011;70:30-40.
7. Munger KL, Zhang SM, O'Reilly E, et al. Vitamin D intake and incidence of multiple sclerosis. Neurology 2004;62:60-5. (Pubitemid 38082871)
8. van der Mei IA, Ponsonby AL, Dwyer T, et al. Past exposure to sun, skin phenotype, and risk of multiple sclerosis: case-control study. BMJ 2003;327:316.
9. Steffensen LH, Mellgren SI, Kampman MT. Outdoor activities and diet in childhood and adolescence relate to MS risk above the arctic circle. J Neurol 2010;257:410-18.
10. Munger KL, Levin LI, Hollis BW, et al. Serum 25-hydroxyvitamin D levels risk multiple sclerosis. JAMA 2006;296:2832-8. (Pubitemid 44969183)
11. Soilu-Hänninen M, Laaksonen M, Laitinen I, et al. A longitudinal study of serum 25-hydroxyvitamin D and intact parathyroid hormone levels indicate the importance of vitamin D and calcium homeostasis regulation in multiple sclerosis. J Neurol Neurosurg Psychiatry 2008;79:152-7. (Pubitemid 351236545)
12. Simpson S Jr, Taylor B, Blizzard L, et al. Higher 25-hydroxyvitamin D is associated with lower relapse risk in multiple sclerosis. Ann Neurol 2010;68:193-203.
13. Mowry EM, Krupp LB, Milazzo M, et al. Vitamin D status is associated with relapse rate in pediatric-onset multiple sclerosis. Ann Neurol 2010;67:618-24.
14. Smolders J, Menheere P, Kessels A, et al. Association of vitamin D metabolite levels with relapse rate and disability in multiple sclerosis. Mult Scler 2008;14:1220-4.
15. Nieves J, Cosman F, Herbert J, et al. High prevalence of vitamin D deficiency and reduced bone mass in multiple sclerosis. Neurology 1994;44:1687-92. (Pubitemid 24286648)
16. Auer DP, Schumann EM, Kümpfel T, et al. Seasonal fluctuations of gadolinium-enhancing magnetic resonance imaging lesions in multiple sclerosis. Ann Neurol 2000;472:276-7. (Pubitemid 30078583)
17. Embry AF, Snowdon LR, Vieth R. Vitamin D and seasonal fluctuations of gadolinium-enhancing magnetic resonance imaging lesions in multiple sclerosis. Ann Neurol 2000;48:271-2. (Pubitemid 30617053)
18. Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis. 2005 revisions to the "McDonald Criteria". Ann Neurol 2005;58:840-6. (Pubitemid 41746873)
19. Wiendl H, Toyka KV, Rieckmann P, et al. Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol 2008;255:1449-63.
20. Kieseier BC, Stüve O. Multiple sclerosis: combination therapy in MS - still a valid strategy. Nat Rev Neurol 2011;7:659-60.
21. Soelberg Sorensen P, Lycke J, Erälinna JP, et al. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol 2011;10:691-701.
22. Cantorna MT, Hayes CE, DeLuca HF. 1,25-Dihydroxyvitamin D3 reversibly blocks the progression of relapsing encephalomyelitis, a model of multiple sclerosis. Proc Natl Acad Sci U S A 1996;93:7861-4. (Pubitemid 26277129)
23. Cantorna MT. Mechanisms underlying the effect of vitamin D on the immune system. Proc Nutr Soc 2010;69:286-9.
24. Kieseier BC. The mechanism of action of interferon-β in relapsing multiple sclerosis. CNS drugs 2011;25:491-502.
25. Jagannath VA, Fedorowitch Z, Asokan GV, et al. Vitamin D for the management of multiple sclerosis (review). Cochrane Database Syst Rev 2010;12:1-12.
26. Burton JM, Kimball S, Vieth R, et al. A phase I/II dose-escalating trial of vitamin D3 and calcium in multiple sclerosis. Neurology 2010;8:1852-9.
27. McDowell TY, Amr S, Culpepper WJ, et al. Sun exposure, vitamin D intake progression disability among veterans progressive multiple sclerosis. Neuroepidemiology 2011;37:52-7.
28. Dawson-Hughes B. Serum 25-hydroxyvitamin D and muscle atrophy in the elderly. Proc Nutr Soc 2012;71:46-9.
29. Kimball SM, Ursell MR, O'Connor P, et al. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr 2011;86:645-51. (Pubitemid 47435831)
30. Mowry E, Waubant E, McCulloch C, et al. Higher vitamin D levels are associated with the development of fewer T2- and gadolinium-enhancing brain MRI lesions in multiple sclerosis. Mult Scler J 2011;17:S129.
31. Stein MS, Liu Y, Gray OM, et al. A randomized trial of high-dose vitamin D2 in relapsing-remitting multiple sclerosis. Neurology 2011;77:1611-18.
32. Steffensen LH, Jørgensen L, Straume B, et al. Can vitamin D supplementation prevent bone loss in persons with MS? A placebo-controlled trial. J Neurol 2011;2589:1624-31.
33. Mosayebi G, Ghazavi A, Ghasami K, et al. Therapeutic effect of vitamin D3 in multiple sclerosis patients. Immunol Invest 2011;40:627-39.