Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00940719|
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Dietary Supplement: vitamin D3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||July 2010|
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)
- T cell regulation [ Time Frame: 3 months ]
- serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ]
- calcium metabolism [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|