Objectives: To study the safety and efficacy of vitamin D3 as an add on therapy to interferon -1b (IFNB) in patients with multiple sclerosis (MS).
Methods: 1 year, double blind, placebo controlled, randomised study in 66 MS patients. The primary outcomes were T2 burden of disease (BOD) on MRI scans, proportion of patients with serum levels of 25-hydroxyvitamin D (25(OH)D) 85 nmol/l or intact parathyroid hormone (PTH) 20 ng/l, and number of adverse events. Secondary outcomes were number of MRI enhancing T1 lesions and new T2 lesions, annual relapse rate, changes in the Expanded Disability Status Scale score, timed 25 foot walk test and timed 10 foot tandem walk tests.
Results: Median change in BOD was 287 mm(3) in the placebo group and 83 mm(3) in the vitamin D group (p=0.105). Serum levels of 25(OH)D increased from a mean of 54 (range 19-82) nmol/l to 110 (range 67-163) nmol/l in the vitamin D group. 84% of patients reached a serum 25(OH)D level >85 nmol/l in the vitamin D group and 3% in the placebo group (p less than 0.0001). Patients in the vitamin D group showed fewer new T2 lesions (p=0.286) and a significantly lower number of T1 enhancing lesions (p=0.004), as well as a tendency to reduced disability accumulation (p=0.071) and to improved timed tandem walk (p=0.076). There were no significant differences in adverse events or in the annual relapse rate.
Conclusion: Vitamin D3 add on treatment to IFNB reduces MRI disease activity in MS.
"This study investigated vitamin D3 as an add-on treatment to interferon-β1b in 66 patients with relapsing–remitting MS (RRMS). Patients were randomly assigned to receive placebo or vitamin D3 (20,000 IU once weekly) for a year. At the end of the study, patients in the vitamin D group showed improvement on MRI measures.This study contrasts to a recent previous paper which showed no effect of vitamin D3 supplementation on MS-related outcomes in patients with RRMS. One possible explanation is a potential synergistic effect of vitamin D and interferon-β1b. However, a key issue is the small sample sizes (<100 patients) used in these trials which make them underpowered and unreliable to address clinical outcomes. In this regard, a Phase II trial (SOLAR), assessing the efficacy of vitamin D as an add-on treatment to interferon-β1b, is currently recruiting patients with RRMS, which is estimated to include 358 patients and to be completed in 2014."
Labels: Vitamin D