PrevANZ Vitamin D MS
Progress report - December 2014
PrevANZ is a
world-first clinical trial that will test whether oral vitamin D
supplementation can prevent MS in those at risk of developing the disease.
Funded by MS
Research Australia with the support of many generous donors, including the Trish Foundation, and managed by a
Steering Committee of Australian and New Zealand MS and vitamin D experts, this
gold-standard clinical trial will focus on the possibility of using oral
vitamin D supplementation to prevent a diagnosis of MS following a person’s
presentation with a first ‘attack’ suggestive of MS.
There is a great
deal of evidence to suggest that vitamin D deficiency plays a role in the
development and also the severity of MS. However, to date there is no
definitive evidence on the benefits that can be expected from vitamin D
supplementation, the optimum dosage, or safety in people at risk of developing
The PrevANZ trial
will investigate whether oral supplementation with one of three doses of
Vitamin D3 - 1000 international units (I.U), 5000 I.U., and 10,000 I.U. in
comparison with placebo capsules - can prevent or delay a diagnosis of MS as
defined by a second relapse or new lesions observed by MRI scans.
We aim to recruit
240 patients with CIS from around Australia and New Zealand. Each patient will
be treated for a period of 48 weeks. The trial will take a total of four years
to complete with results expected in 2017.
This is an area
in which the expertise in Australia and New Zealand is second to none. This is
our opportunity to have a major impact in the prevention and better treatment
of MS globally.
With the funding for PrevANZ
secured in 2012, the planning phase commenced and logistical preparations were
well underway in early 2013. Applications for ethics and regulatory approvals
were completed, trial sites were selected, budgets finalised and collaborative
clinical trial agreements established with each site.
The majority of trial sites
were initiated in the final quarter of 2013, with the remaining few up and
running in early 2014. In total, twenty trial sites, 15 in Australia and five
in New Zealand, have now been initiated and are actively recruiting participants.
These trial sites are run by highly experienced MS specialist neurologists and
As at December 2014, 54
patients have been enrolled in the trial with more currently undergoing
The working group (contract
research organisation, MSRA, PrevANZ Principal Investigators) continue to hold
fortnightly teleconferences to coordinate all logistical aspects of the trial,
monitor recruitment and address enquiries and issues as they arise. The
Steering Committee meet quarterly to oversee all aspects of the trial.
Data collection via the electronic Case Report Form is
running very smoothly and no safety issues have emerged for patients.
The Trish Foundation is proud to have made a contribution to
this important Trial.