Vitamin D prevention trial for MS will commence in 2012
6th July, 2012
This world-first trial will commence patient recruitment in the second quarter of 2012. PrevANZ is a ‘gold-standard’ placebo controlled trial which will determine the efficacy of high dose vitamin D to prevent MS in people at high risk of developing the condition - those experiencing their very first episode of MS symptoms.
Approximately 80% of people who experience a first attack of MS-like symptoms (also known as Clinically Isolated Syndrome or CIS) will go on to experience a second episode or show further disease activity visible as lesions in an MRI scan, resulting in a diagnosis of clinically definite MS. There are currently no evidence-based interventions to prevent the development of MS in these people.
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. This study confirmed a significantly higher incidence of MS in the southern centres (further from the Equator with lower incident UV radiation which is required for vitamin D synthesis in the skin). 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.
The PrevANZ trial will test 3 dosage levels of daily vitamin D supplements (1000, 5000 & 10,000 International Units) against placebo (dummy tablets). A collaborative Australian/NZ research team will undertake this study, to be coordinated by MSRA and led by A/Prof Helmut Butzkueven from the Department of Medicine, University of Melbourne, and Prof Bruce Taylor, Menzies Research Institute Tasmania.
The team will specifically investigate whether a beneficial clinical or pathological response (measured by reduced clinical relapse and reduced lesions visible via MRI scans) exists for oral vitamin D supplementation after CIS and whether there is a relationship between the serum levels of vitamin D achieved and prevention of a further relapse. They will also assess whether the intervention has an acceptable safety profile for people who have had a CIS.
The study is due to start in the second quarter of 2012 and will run for 4 years to 2016.
Further information will be available on this website once recruitment is open.