Efficacy of vitamin D3 as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial

Journal of the Neurological Sciences

Volumn 311, Issue 1-2, 2011, Pages 44-49

  Smolders, Joost ^a   Hupperts, Raymond ^b   Barkhof, Frederik ^c   Grimaldi, Luigi M E ^d   Holmoy, Trygve ^e,i,l   Killestein, Joep ^c   Rieckmann, Peter ^f   Schluep, Myriam ^g   Vieth, Reinhold ^h   Hostalek, Ulrike ⁱ   Ghazi Visser, Lizette ^j   Beelke, Manolo ^k  

^a MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^b Sittard Geleen Heerlen   (Netherlands)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d Fondazione Istituto San Raffaele G Giglio di Cefalu   (Italy)

^e AKERSHUS UNIVERSITY HOSPITAL   (Norway)

^f UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^g LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^h MOUNT SINAI HOSPITAL   (Canada)

ⁱ MERCK KGAA   (Germany)

^j Merck BV   (Netherlands)

^k MERCK SERONO S A   (Switzerland)

^l UNIVERSITY OF OSLO   (Norway)

more..

Author keywords

1,25 Dihydroxyvitamin D; 25 Hydroxyvitamin D; Biomarker; Clinical trial; Interferon beta 1a; Multiple sclerosis; SOLAR; Vitamin D

Indexed keywords

25 HYDROXYVITAMIN D; BETA1A INTERFERON; CALCIUM; COLECALCIFEROL; CREATININE; BETA INTERFERON;

ADD ON THERAPY; ADULT; ARTICLE; CALCIUM BLOOD LEVEL; CALCIUM URINE LEVEL; CONTROLLED STUDY; CREATININE URINE LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EVENING DOSAGE; FEMALE; GENE EXPRESSION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PHARMACOGENETICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VITAMIN SUPPLEMENTATION; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DIET SUPPLEMENTATION; DRUG POTENTIATION; IMMUNOLOGY; METABOLISM; MIDDLE AGED; STANDARD; VITAMIN D DEFICIENCY;

ADOLESCENT; ADULT; CHOLECALCIFEROL; DIETARY SUPPLEMENTS; DOUBLE-BLIND METHOD; DRUG SYNERGISM; FEMALE; HUMANS; INTERFERON-BETA; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; VITAMIN D DEFICIENCY; YOUNG ADULT;

EID: 81255152070     PISSN: 0022510X     EISSN: 18785883     Source Type: Journal    
DOI: 10.1016/j.jns.2011.04.013     Document Type: Article

References (34)

1. A. Compston, and A. Coles Multiple sclerosis Lancet 372 2008 1502 1517
2. IFNB Multiple Sclerosis Study Group Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial Neurology 43 1993 655 661
3. L.D. Jacobs, D.L. Cookfair, R.A. Rudick, R.M. Herndon, J.R. Richert, and A.M. Salazar Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis Ann Neurol 39 1996 285 294 (Pubitemid 26100751)
4. K.P. Johnson, B.R. Brooks, J.A. Cohen, C.C. Ford, J. Goldstein, and R.P. Lisak Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial Neurology 45 1995 1268 1276
5. PRISMS Study Group Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis Lancet 352 1998 1498 1504
6. B.G. Weinshenker, B. Bass, G.P. Rice, J. Noseworthy, W. Carriere, and J. Baskerville The natural history of multiple sclerosis: a geographically based study. 1. Clinical course and disability Brain 112 Pt 1 1989 133 146 (Pubitemid 19056478)
7. A. Ascherio, K.L. Munger, and K.C. Simon Vitamin D and multiple sclerosis Lancet Neurol 9 2010 599 612
8. J. Smolders, P. Menheere, A. Kessels, J. Damoiseaux, and R. Hupperts Association of vitamin D metabolite levels with relapse rate and disability in multiple sclerosis Mult Scler 14 2008 1220 1224
9. C. Pierrot-Deseilligny Clinical implications of a possible role of vitamin D in multiple sclerosis J Neurol 256 2009 1468 1479
10. S.M. Orton, A.P. Morris, B.M. Herrera, S.V. Ramagopalan, M.R. Lincoln, and M.J. Chao Evidence for genetic regulation of vitamin D status in twins with multiple sclerosis Am J Clin Nutr 88 2008 441 447
11. M.J. Jongen, W. van der Vijgh, P. Lips, and J.C. Netelenbos Measurement of vitamin D metabolites in anephric subjects Nephron 36 1984 230 234 (Pubitemid 14192562)
12. J.S. Adams, and M. Hewison Unexpected actions of vitamin D: new perspectives on the regulation of innate and adaptive immunity Nat Clin Pract Endocrinol Metab 4 2008 80 90 (Pubitemid 351156900)
13. S. Simpson, B. Taylor, L. Blizzard, A.L. Ponsonby, F. Pittas, and H. Tremlett Higher 25-hydroxyvitamin D is associated with lower relapse risk in multiple sclerosis Ann Neurol 68 2010 193 203
14. E.M. Mowry, L.B. Krupp, M. Milazzo, D. Chabas, J.B. Strober, and A.L. Belman Vitamin D status is associated with relapse rate in pediatric-onset multiple sclerosis Ann Neurol 67 2010 618 624
15. M. Soilu-Hanninen, L. Airas, I. Mononen, A. Heikkila, M. Viljanen, and A. Hanninen 25-Hydroxyvitamin D levels in serum at the onset of multiple sclerosis Mult Scler 11 2005 266 271 (Pubitemid 40775180)
16. J. Correale, M.C. Ysrraelit, and M.I. Gaitan Immunomodulatory effects of Vitamin D in multiple sclerosis Brain 132 2009 1146 1160
17. S.V. Ramagopalan, N.J. Maugeri, L. Handunnetthi, M.R. Lincoln, S.M. Orton, and D.A. Dyment Expression of the multiple sclerosis-associated MHC class II Allele HLA-DRB1*1501 is regulated by vitamin D PLoS Genet 5 2009 e1000369
18. C.E. Hayes, M.T. Cantorna, and H.F. DeLuca Vitamin D and multiple sclerosis Proc Soc Exp Biol Med 216 1997 21 27
19. C.D. Tsoukas, D.M. Provvedini, and S.C. Manolagas 1,25-Dihydroxyvitamin D3: a novel immunoregulatory hormone Science 224 1984 1438 1440
20. C.D. Tsoukas, D. Watry, S.S. Escobar, D.M. Provvedini, C.A. Dinarello, and F.G. Hustmyer Inhibition of interleukin-1 production by 1,25- dihydroxyvitamin D3 J Clin Endocrinol Metab 69 1989 127 133
21. J. Smolders, M. Thewissen, E. Peelen, P. Menheere, J.W. Tervaert, and J. Damoiseaux Vitamin D status is positively correlated with regulatory T cell function in patients with multiple sclerosis PLoS One 4 2009 e6635
22. J.M. Burton, S. Kimball, R. Vieth, A. Bar-Or, H.M. Dosch, and R. Cheung A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis Neurology 74 2010 1852 1859
23. E. van Etten, C. Gysemans, D.D. Branisteanu, A. Verstuyf, R. Bouillon, and L. Overbergh Novel insights in the immune function of the vitamin D system: synergism with interferon-beta J Steroid Biochem Mol Biol 103 2007 546 551 (Pubitemid 46401359)
24. P. Goldberg, M.C. Fleming, and E.H. Picard Multiple sclerosis: decreased relapse rate through dietary supplementation with calcium, magnesium and vitamin D Med Hypotheses 21 1986 193 200 (Pubitemid 17201931)
25. S.M. Kimball, M.R. Ursell, P. O'Connor, and R. Vieth Safety of vitamin D3 in adults with multiple sclerosis Am J Clin Nutr 86 2007 645 651 (Pubitemid 47435831)
26. B.D. Mahon, S.A. Gordon, J. Cruz, F. Cosman, and M.T. Cantorna Cytokine profile in patients with multiple sclerosis following vitamin D supplementation J Neuroimmunol 134 2003 128 132 (Pubitemid 36050838)
27. J. Smolders, E. Peelen, M. Thewissen, J.W. Cohen Tervaert, P. Menheere, and R. Hupperts Safety and T cell modulating effects of high dose vitamin D3 supplementation in multiple sclerosis PLoS One 5 2010 e15235 e
28. B.W. Hollis, C.L. Wagner, M.K. Drezner, and N.C. Binkley Circulating vitamin D3 and 25-hydroxyvitamin D in humans: an important tool to define adequate nutritional vitamin D status J Steroid Biochem Mol Biol 103 2007 631 634 (Pubitemid 46401311)
29. K.L. Munger, L.I. Levin, B.W. Hollis, N.S. Howard, and A. Ascherio Serum 25-hydroxyvitamin D levels and risk of multiple sclerosis JAMA 296 2006 2832 2838 (Pubitemid 44969183)
30. R. Vieth What is the optimal vitamin D status for health? Prog Biophys Mol Biol 92 2006 26 32 (Pubitemid 43842065)
31. R.P. Heaney, K.M. Davies, T.C. Chen, M.F. Holick, and M.J. Barger-Lux Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol Am J Clin Nutr 77 2003 204 210 (Pubitemid 36015393)
32. R.P. Heaney Vitamin D: criteria for safety and efficacy Nutr Rev 66 2008 S178 S181
33. J. Maalouf, M. Nabulsi, R. Vieth, S. Kimball, R. El-Rassi, and Z. Mahfoud Short- and long-term safety of weekly high-dose vitamin D3 supplementation in school children J Clin Endocrinol Metab 93 2008 2693 2701 (Pubitemid 352008538)
34. C.H. Polman, S.C. Reingold, G. Edan, M. Filippi, H.P. Hartung, and L. Kappos Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria" Ann Neurol 58 2005 840 846 (Pubitemid 41746873)