Network: The Irish MS clinical trials network will involve 5 centres with proven experience in research in MS in Dublin, Cork and Belfast. The aims will be, using consultant neurologists and MS research nurses at each centre: 1) to introduce and apply standardised protocols for disease modifying therapy (DMT) initiation, monitoring disease control (including annual MRI scans), identifying breakthrough activity, and escalating DMT. Through web-based data entry we will record observational data on MS patients. 2) All new MS patients will a) be offered entry to the trial described below and b) be entered into a prospective MS database, recording baseline demographic, clinical and MRI data, vitamin D levels and collecting prospectively, DNA, serum and CSF to be stored at -80oC. The network objective is to optimise MS management outcomes and to prevent disability and cerebral atrophy.
Trial: Dimethyl fumarate (DMF) has demonstrated partial efficacy in reducing relapses and disability progression in RRMS. We hypothesise that combined treatment with DMF and high dose vitamin D will reduce both inflammatory disease activity and cerebral atrophy. Patients with the CIS or early RRMS (n= 628) will be recruited in multiple centres throughout Ireland, Scotland and Finland and randomised to either a) DMF 480 mgs daily and 10,000 IU vitamin D daily or b) DMF 480 mgs daily and 1000 IU vitamin D for 96 weeks. The co-primary efficacy endpoints will be (i) the effect on annualised relapse rates over the 96 weeks and (ii) the effects on a MRI measure of cerebral atrophy, between baseline, 48 and 96 weeks compared between the two treatment groups. This study has high public health implications since vitamin D deficiency is endemic in Europe and is a cost-effective therapy, which has been inadequately investigated to date. A further trial of vitamin D in pregnancy is planned.
