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 MS Research Australia and led by Professor Helmut Butzkueven from the Department of Medicine, University of Melbourne, and Prof Bruce Taylor, Menzies Institute for Medical Research.
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.