The vitamin D MS Prevention Trial – PrevANZ is a world-first clinical trial that will test whether vitamin D supplementation can prevent MS in those at risk of developing the disease.
This is a Phase IIb randomised, double blind, placebo-controlled trial testing a range of doses of oral vitamin D supplements in people with a first episode of symptoms that may be a precursor to MS (known as clinically isolated syndrome or CIS). This might include symptoms such as blurred vision (optic neuritis) or limb weakness (transverse myelitis) (these symptoms may also be described as a first demyelinating event).
The trial will test whether vitamin D supplements can delay or prevent a second episode, or attack, which would lead to a diagnosis of MS. It also tests the appropriate dosage levels and safety.
The need for the vitamin D MS prevention trial has arisen from a now significant body of evidence for the role that vitamin D deficiency plays in MS. However, to date there has not been a clinical trial conducted to provide the necessary evidence on the benefits that can be expected from vitamin D supplementation or the correct dose.
MS Research Australia and our colleagues in the MS research community see this trial as a high priority and an area in which the expertise in Australia and New Zealand can contribute significantly to the prevention and better treatment of MS globally.
A team of clinicians and researchers from Australia and New Zealand, with expertise in MS neurology, MS clinical trials, endocrinology and epidemiology has been assembled to oversee the trial. The trial is coordinated and funded by MS Research Australia. This has been made possible by generous support from the state MS organisations, particularly, WA, Queensland and Tasmania, as well as Foundation 5 Million+, the Trish MS Research Foundation, and the John T Reid Trust.
Together with the Steering Committee, chaired by Professor Bill Carroll from the Sir Charles Gairdner Hospital, Perth, a collaborative team of neurologists, led by Professor Helmut Butzkueven from the University of Melbourne, and Professor Bruce Taylor, Menzies Institute for Medical Research, Hobart, will undertake this study across 18 sites in Australia and New Zealand.
The vitamin D MS Prevention Trial commenced recruitment in June 2013. The trial aims to enrol 240 people with CIS. It is expected the trial will be complete in 2019. The trial will test 3 dosage levels of daily oral vitamin D3 supplements (1000, 5000 & 10,000 International Units) against placebo (dummy tablets) .
The evidence for the role of vitamin D deficiency in MS is now very strong and was reinforced by the internationally important Australian study (Ausimmune, 2004-2007), comparing MS patients in with CIS in Brisbane, Newcastle, Geelong and Hobart. Vitamin D deficiency is thought to play a role in MS since geographical areas of lower levels of UV radiation, and hence lower vitamin D synthesis in the skin, have higher incidences of MS. Variations in genes involved in the vitamin D metabolism pathway have been implicated in susceptibility to MS and vitamin D deficiency has also been shown to be associated with a higher rate of relapses in people with established MS.
People with CIS who are interested in taking part should discuss participation with their neurologist. The sites for the trial are listed below. Full details of the trial, including eligibility criteria for participants can be found here.
Please note people who have already been diagnosed with MS are not eligible to participate in the trial. People with MS who are concerned about their vitamin D levels should seek advice from their GP or neurologist.
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|NSW||Sydney||Save Sight Institute||Dr Clare Fraser||Amanda Dinh||02 9382 7300|
|NSW||Newcastle||John Hunter Hospital||Associate Professor Jeannette Lechner-Scott||Nicole Lingard||02 4921 3540|
|NSW||Sydney||Brain and Mind Centre||Dr Todd Hardy||Marinda Taha||02 9351 0730|
|VIC||Geelong||Geelong Hospital||Dr Cameron Shaw||Sharon Jones||03 4215 0710|
|VIC||Melbourne||Royal Melbourne Hospital||Professor Helmut Butzkueven||Sandra Williams||03 9342 7061|
|VIC||Melbourne||Box Hill Hospital||Professor Helmut Butzkueven||Alicia Redderhof||03 9095 2447|
|VIC||Melbourne||Austin Health||Professor Richard Macdonell||Melanie McMurtrie||03 9496 5529|
|VIC||Melbourne||Monash Neurology||Associate Professor Ernie Butler||Wendy Hayes||03 9871 0997|
|QLD||Gold Coast||Griffith University/Gold Coast Hospital||Professor Simon Broadley||Susan Freeman||07 5678 0750|
|QLD||Brisbane||Wesley Research Institute||Professor Pam McCombe||Ria Halstead||07 3721 1523|
|SA||Adelaide||Calvary Wakefield Hospital||Dr Andrew Lee||Paul Stockle||08 8132 0494|
|WA||Perth||Australian Neuromuscular Research Institute||Professor William Carroll||Susan Walters||08 9346 3980|
|TAS||Hobart||Royal Hobart Hospital||Professor Bruce Taylor||Sue McGregor||03 6222 8323|
|NZ||Auckland||Auckland Hospital||Dr Ernie Willoughby||Roddi Laurence||09 307 4949
|NZ||Christchurch||Christchurch Hospital||Dr Deborah Mason||Jane Eagle||03 378 6130|
|NZ||Dunedin||Dunedin Hospital||Dr John Mottershead||Sharon Stevenson-Hall||03 470 0999|
|NZ||Waikato||Waikato Hospital||Dr Chris Lynch||Linda Gilbertson||02 154 9778|
|NZ||Wellington||Wellington Hospital||Dr David Abernethy||Liz Goode||04 806 0078|
Professor William Carroll – Sir Charles Gairdner Hospital, WA
Professor Helmut Butzkueven – University of Melbourne, VIC
Professor Bruce Taylor – Menzies Institute for Medical Research, TAS
Professor Anne-Louise Ponsonby – Murdoch Children’s Research Institute,VIC
Professor Simon Broadley – Griffith University, QLD
Dr Deborah Mason – New Zealand Brain Research Institute, Christchurch, NZ
Dr Robyn Lucas – Australian National University, ACT
Dr Keith Dear – Australian National University, ACT
Dr Mark Stein – Royal Melbourne Hospital, VIC
Professor Peter Mitchell – The University of Melbourne, VIC
Professor Trevor Kilpatrick – Florey Institute of Neuroscience and Mental Health, VIC
Associate Professor Jeannette Lechner-Scott – Hunter Medical Research Institute, NSW
Associate Professor Michael Barnett – Brain and Mind Research Institute, The University of Sydney, NSW