A randomized trial of high-dose vitamin D2 in relapsing-remitting multiple sclerosis
MS Stein, Y Liu, OM Gray, JE Baker, SC Kolbe, MR Ditchfield, GF Egan, PJ Mitchell, LC Harrison, H Butzkueven, TJ Kilpatrick
Neurology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2011
OBJECTIVE: Higher latitude, lower ultraviolet exposure, and lower serum 25-hydroxyvitamin D (25OHD) correlate with higher multiple sclerosis (MS) prevalence, relapse rate, and mortality. We therefore evaluated the effects of high-dose vitamin D2 (D2) in MS. METHODS: Adults with clinically active relapsing-remitting MS (RRMS) were randomized to 6 months' double-blind placebo-controlled high-dose vitamin D2, 6,000 IU capsules, dose adjusted empirically aiming for a serum 25OHD 130-175 nM. All received daily low-dose (1,000 IU) D2 to prevent deficiency. Brain MRIs were performed at baseline, 4, 5, and 6 months. Primary endpoints were the cumulative number of new gadolinium-enhancing lesions and..View full abstract
Awarded by National Science Foundation of China
Funded by The Myer Foundation, which had no influence on trial design, data collection, or analyses. Dr. Liu was supported by a Multiple Sclerosis International Federation McDonald Fellowship and Prof. Harrison is NHMRC Senior Principal Research Fellow.Dr. Stein received research support from The Myer Foundation. Dr. Liu received the McDonald Fellowship from The Multiple Sclerosis International Federation and support from the National Science Foundation of China (No. 81101038). Dr. Gray served on a scientific advisory board for Merck Serono and has received unrestricted educational awards from Merck Serono and Biogen Idec. J.E. Baker has received funding for travel to attend educational meetings from Bayer Schering Pharma, Sanofi-Aventis, Biogen Idec, and Merck Serono. Dr. Kolbe received research/fellowship support from Multiple Sclerosis Research Australia and the National MS Society (USA). Dr. Ditchfield received speaker honoraria from Siemens and Toshiba. Dr. Egan serves on an Australian Research Council (ARC) college of experts panel; serves on a scientific advisory board for Neurosciences Victoria; serves as Associate Editor for Human Brain Mapping and on the editorial boards of Neuroimage and the Journal of Imaging Technology; and receives research support from National Health Medical Research Council Australia, ANZ Trustees, Melbourne, Australia, the Australian Research Council, the Australian Government Department of Industry, Innovation, Science and Research, the National Multiple Sclerosis Society (USA), and Cure Huntington's Disease initiative (CHDI). Dr. Mitchell serves as an Associate Editor for the Journal of Medical Imaging and Radiation Oncology; performs neuroimaging in his clinical practice (75% effort) and bills for these procedures; serves on scientific advisory boards for Cordis Corporation, Johnson & Johnson, and Boston Scientific; and receives research support from Boston Scientific, Talecris Biotherapeutics, The Myer Foundation, and National Health Medical Research Council Australia. Dr. Harrison serves on the editorial boards of Diabetes Metabolism Reviews, Diabetes Research and Clinical Practice, Current Diabetes Reports, and Pediatric Diabetes, as Contributing Editor for Molecular Medicine, and as Associate Editor for Human Vaccines; serves as a consultant for Bayhill Therapeutics; and receives research support from The Myer Foundation, National Health and Medical Research Council (NHMRC) of Australia, and the Juvenile Diabetes Research Foundation. Dr. Butzkueven has received funding for travel from and served on scientific advisory boards for Biogen Idec, Novartis, and Sanofi-Aventis; serves on the editorial board of Multiple Sclerosis International; holds patents for treatment application of LIF in MS and treatment application of EPHA4 blockade in MS; and receives research support from Merck Serono, Biogen Idec, Novartis, National Health and Medical Research Council (NHMRC), and National MS Society (USA). Dr.Kilpatrick has served on scientific advisory boards for GlaxoSmithKline, Neurosciences Victoria, and the Victorian Neurotrauma Initiative; has received funding for travel from Bayer Schering Pharma, SanofiAventis, and Merck Serono; served on the editorial board of Therapeutic Advances in Neurological Disorders; is listed as an inventor on patents re: HIV test kit method for detecting anti-HIV-1 antibodies in saliva; A method of modulating cell survival and reagents useful for the same; Methods for the treatment and prophylaxis of demyelinating disease; and Method of treatment in the field of inflammatory neurodegeneration; and receives research support from Bayer Schering Pharma, Biogen Idec, the Australian Research Council, the National Health and Medical Research Council of Australia, MS Research Australia, and National Multiple Sclerosis Society USA), and The Myer Foundation.