Trial | NCT00940719  Report issue

Title

Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)
The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    15
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.
Study Started
Aug 31
2009
Primary Completion
Mar 31
2010
Study Completion
Jul 31
2010
Last Update
Aug 11
2010
Estimate

Dietary Supplement vitamin D3

Oil-based solution, 1 dose of 500 microgram each day, during 3 months.

  • Other names: Vigantol Oil (Merck)

Vitamin D3 Experimental

Patients receive 1dd 500ug vitamin D3 for 3 months

Criteria 

Inclusion Criteria:

Relapsing Remitting MS (Revised MCDonald criteria 2005)
Age > 18 years

Exclusion Criteria:

Progressive MS phenotype
Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure
Intake of drugs that influence vitamin D homeostasis other than corticosteroids
Conditions with in increased susceptibility to hypercalcemia
Alcohol or drug abuse
Pregnancy or the intention to become pregnant within the study period
No Results Posted