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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00940719

Collaborator

Orbis Medical Centre (Other)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Dietary Supplement: vitamin D3	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

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 :

Aug 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Vigantol Oil (Merck)

Arm

Intervention/Treatment

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 Names:

Vigantol Oil (Merck)

Outcome Measures

Primary Outcome Measures

T cell regulation [3 months]

Secondary Outcome Measures

serum 25-hydroxyvitamin D levels [3 months]
calcium metabolism [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orbis Medical Center	Sittard		Netherlands	6130MD

Sponsors and Collaborators

Maastricht University Medical Center
Orbis Medical Centre

Investigators

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