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PrevANZ Vitamin D MS Prevention Trial

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 MS.

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 clinical triallists.

As at December 2014, 54 patients have been enrolled in the trial with more currently undergoing eligibility assessment.

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.

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