Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D3


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>Patients receive 1dd 500ug vitamin D3 for 3 months | Dietary Supplement: vitamin D3<br>* Oil-based solution, 1 dose of 500 microgram each day, during 3 months.<br>* Other names: Vigantol Oil (Merck);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell regulation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25-hydroxyvitamin D levels |  | 3 months | 
| calcium metabolism |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Regulatory T cell function, Vitamin D, Vitamin D3, 25-hydroxyvitamin D