PrevANZ

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.

MSRA 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 MSRA. 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/Prof Helmut Butzkueven from the Department of Medicine, University of Melbourne, and Prof 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
NSW	Liverpool	Liverpool Hospital	Dr Suzanne Hodgkinson
NSW	Newcastle	John Hunter Hospital	A/Prof Jeannette Lechner-Scott
NSW	Sydney	Brain Mind Research Institute (Sydney University)	Dr Michael Barnett
NSW	Sydney	Royal North Shore Hospital	Dr John Parratt
NSW	Westmead	Westmead Millennium Institute	A/Prof Steve Vucic
VIC	Geelong	Geelong Hospital	Dr Cameron Shaw
VIC	Melbourne	Royal Melbourne Hospital	A/Prof Helmut Butzkueven
VIC	Melbourne	Box Hill Hospital	A/Prof Helmut Butzkueven
VIC	Melbourne	Austin Health	Prof Richard Macdonell
VIC	Melbourne	St Vincents Hospital	Dr Mark Paine
VIC	Melbourne	Monash Neurology	A/Prof Ernie Butler
QLD	Brisbane	Royal Brisbane and Womens Hospital	Dr Stefan Blum
QLD	Gold Coast	Gold Coast Hospital	Prof Simon Broadley
SA	Adelaide	Flinders Medical Centre	Dr Mark Slee
WA	Perth	Australian Neuromuscular Research Institute	Prof William Carroll
TAS	Hobart	Royal Hobart Hospital	Prof Bruce Taylor
NZ	Auckland	Auckland Hospital	Dr Ernie Willoughby
NZ	Christchurch	Christchurch Hospital	Dr Deborah Mason
NZ	Dunedin	Dunedin Hospital	Dr John Mottershead
NZ	Hamilton	Hamilton Hospital	Dr Chris Lynch
NZ	Wellington	Wellington Hospital	Dr David Abernethy

PrevANZ Steering Committee

• Prof William Carroll, Sir Charles Gairdner Hospital, Perth
• A/Prof Helmut Butzkueven, University of Melbourne, Melbourne
• Prof Bruce Taylor, Menzies Research Institute Tasmania, Hobart
• Prof Anne-Louise Ponsonby, Murdoch Children’s Research Institute, Melbourne
• Prof Simon Broadley, Griffith University, Gold Coast
• 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, Melbourne
• Prof Peter Mitchell, Royal Melbourne Hospital, Melbourne
• Prof Trevor Kilpatrick, Florey Neuroscience Institutes, Melbourne