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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Dietary Supplement: vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT00940719

MUMC09T43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Vitamin D3

Experimental group

Description:

Patients receive 1dd 500ug vitamin D3 for 3 months

Treatment:

Dietary Supplement: vitamin D3