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A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon {beta}-1b in patients with multiple sclerosis
Journal of Neurology, Neurosurgery & Psychiatry, 03/09/2012
Exclusive author commentary
Clinical Article
Soilu–Hanninen M et al. – Vitamin D3 add on treatment to interferon β–1b (IFNB) reduces MRI disease activity in 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.
- Median change in BOD was 287 mm3 in the placebo group and 83 mm3 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<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.
Dr M H Soilu-Hänninen (03/12/2012) comments:
Our paper is the first randomised double-blind placebo controlled trial with vitamin D3 in MS patients with MRI outcomes. The most important results was the statistically significant reduction on Gd+ lesion in the vitamin D3 treated patients in comparison with the placebo group as well as the trends in MRI BOD, EDSS and timed tandem walk test. Our patients had active MS with an ARR of 0.51 before the trial onset and all of them were using interferon-beta 1b. It is possible that interferon-beta and vitamin D3 have a synergistic effects in MS. This is one explanation for the discrepancy with the negative results from another RCT (Kampman et al, Multiple sclerosis Epub ahead of print Feb 2012.
