PrevANZ

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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. The Phase IIb randomised, double blind, placebo-controlled trial will focus on the possibility of using vitamin D supplementation to prevent a diagnosis of MS following a person’s presentation with a first episode of symptoms – people with CIS or clinically isolated syndrome. PrevANZ will also test appropriate dosage levels and safety.

The need for the PrevANZ 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.

The PrevANZ Team

A steering committee 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 will be coordinated and funded by MS Research Australia. This has been made possible by generous support from the state MS organisations, particularly, WA, QLD and Tasmania, as well as Foundation 5 Million+, the Trish MS Research Foundation, and the John T Reid Trust.

A collaborative team of neurologists, lead by A/Professor Helmut Butzkueven from the Department of Medicine, University of Melbourne, and Professor Bruce Taylor, Menzies Research Institute Tasmania, will undertake this study across 21 sites in Australia and New Zealand.

PrevANZ Timeline

PrevANZ will commence recruitment in November 2012 and run for four years over 2013-2016. It is expected that results will be available in 2017. PrevANZ will test 3 dosage levels of daily oral vitamin D supplements (1000, 5000 & 10,000 International Units) against placebo (dummy tablets) in a group of 160 people in the first instance, with expansion to 240 people pending further funding.

While $2.5 million dollars have been secured to fund the trial, a further $1 million is needed to extend the sample size and achieve a robust and conclusive answer.

The role of vitamin D in MS

The evidence for the role of vitamin D deficiency in MS is now very strong and was reinforced by the seminal Australian study (Ausimmune, 2004-2007), comparing MS patients in the CIS category 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.

Taking part in the PrevANZ trial

People with CIS who are interested in taking part should discuss participation with their neurologist. The sites for the trial are being finalised. The likely sites are listed below.

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.

Proposed PrevANZ trial sites:

State Location    Site Investigator Study Coordinator Contact number
NSW Liverpool Liverpool Hospital Dr Suzanne Hodgkinson Sue Baker 02 9616 4689
NSW Newcastle John Hunter Hospital A/Professor Jeannette Lechner-Scott Paula Abrego 02 4921 3540
NSW Sydney Brain and Mind Research Institute (Sydney University) Dr Michael Barnett Marinda Taha 02 9351 0730
NSW Westmead Westmead Hospital A/Professor Steve Vucic Therese Burke 02 9845 8738
NSW Geelong Geelong Hospital Dr Cameron Shaw Sharryn Savickas 03 4215 0710
VIC Melbourne Royal Melbourne Hospital A/Professor Helmut Butzkueven Jo Baker 03 9342 7061
VIC Melbourne Box Hill Hospital A/Professor Helmut Butzkueven Felicity Pearson 03 9095 2426
VIC Melbourne Austin Health Professor Richard Macdonell Belinda Bardsley 03-9496-5529
VIC Melbourne St Vincents Hospital Dr Ann French Tina Chen 03 9288-3557
VIC Melbourne Monash Neurology A/Professor Ernie Butler Wendy Hayes 03 9871 0997
QLD Gold Coast Griffith University/Gold Coast Hospital Professor Simon Broadley Susan Freeman 07 5678 0750
SA Adelaide Flinders Medical Centre A/Professor Mark Slee Maria Toubia 08 8204 4187
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 7765
NZ Auckland Auckland Hospital Dr Ernie Willoughby Roddi Lawrence 09 307 4949 Ext 25816
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 Imogen Milner 04 385 5999

PrevANZ Steering Committee

  • Professor William Carroll, Sir Charles Gairdner Hospital, Perth
  • A/Professor Helmut Butzkueven, University of Melbourne
  • Professor Bruce Taylor, Menzies Research Institute Tasmania
  • Professor Anne-Louise Ponsonby, Murdoch Children’s Research Institute, Melbourne
  • Professor Simon Broadley, Griffith University, Queensland
  • Dr Deborah Mason, New Zealand Brain Research Institute, Christchurch, NZ
  • Dr Robyn Lucas, Australian National University, Canberra
  • Dr Keith Dear, Australian National University, Canberra
  • Dr Mark Stein, Royal Melbourne Hospital
  • Professor Peter Mitchell, Royal Melbourne
  • Professor Trevor Kilpatrick, Florey Institute of Neuroscience and Mental Health, Melbourne
  • Dr Mark Slee, Flinders Medical Centre, Adelaide
  • A/Professor Jeannette Lechner-Scott, Hunter Medical Research Institute, Newcastle
  • A/Professor Michael Barnett, Brain and Mind Research Institute, University of Sydney