Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study|
- T cell regulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- calcium metabolism [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3
Patients receive 1dd 500ug vitamin D3 for 3 months
Dietary Supplement: vitamin D3
Oil-based solution, 1 dose of 500 microgram each day, during 3 months.
Other Name: Vigantol Oil (Merck)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940719
|Orbis Medical Center|
|Sittard, Netherlands, 6130MD|
|Study Director:||Raymond Hupperts, M.D., Ph.D.||Orbis Medical Center Sittard, Maastricht Univeristy Medical Center Maastricht|
|Principal Investigator:||Joost Smolders, M.D.||Maastricht University Medical Center|