Multiple Sclerosis Clinical Trial
Official title:
The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study
In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.
In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related
with vitamin D status. We observed that RRMS patients who remained relapse free before blood
collection had a better vitamin D status than patients who experienced relapses (Smolders et
al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell
regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a
promotion of Treg function in MS patients might underlie its association with MS disease
activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function
with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status
correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the
present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T
cell regulation.
In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T
cell tests will be performed before and after supplementation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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