Low vitamin D status has been consistently associated with an increased risk of multiple sclerosis (MS). Further, preclinical and in vitro data demonstrate immune regulatory properties of 1,25-dihydroxyvitamin D that may be beneficial for patients with MS. To date evidence of beneficial in vivo immunomodulation by supplementation with vitamin D3 in humans is lacking. In a one-year, open-label, phase I/II dose-escalation study of vitamin D3 (average ~14,000 IU/d over one year) with calcium (1,200mg/d) in patients with MS, we compared the effects of treatment on safety outcomes, clinical outcomes and selected biomarkers of immune system activity, relative to matched MS patients [age, sex, disease duration, disease modifying therapy, and expanded disability status scale (EDSS)] randomized to receive no supplementation. Mean serum 25(OH)D concentrations were 78.1±27.0 nmol/L at baseline and at one-year were 82.7±34.8 and 179.1±76.1 nmol/L in control and treated groups, respectively. Serum and urinary calcium and all other safety outcomes were unchanged throughout the trial. Compared to controls, treated patients tended to have fewer relapses (McNemar, p=0.09) and a greater proportion had a stable or improved EDSS at study end (p=0.018). We observed significantly reduced lymphocyte proliferative responses to antigenic challenge in the treatment group at one year, compared to baseline and control group responses. High serum 25(OH)D concentrations were not associated with short-term adverse effects in patients with MS, but with evidence of clinical improvement and beneficial immunomodulation.
| Identifer | oai:union.ndltd.org:TORONTO/oai:tspace.library.utoronto.ca:1807/29775 |
| Date | 31 August 2011 |
| Creators | Kimball, Samantha |
| Contributors | Vieth, Reinhold |
| Source Sets | University of Toronto |
| Language | en_ca |
| Detected Language | English |
| Type | Thesis |
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