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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Dietary Supplement: vitamin D3

• Registration Number: NCT00940719
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Study Start: 2009-08
• Primary Completion: 2010-03
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D3	vitamin D3	Patients receive 1dd 500ug vitamin D3 for 3 months

Primary Outcome Measures

Name	Time	Method
T cell regulation	3 months

Secondary Outcome Measures

Name	Time	Method
serum 25-hydroxyvitamin D levels	3 months
calcium metabolism	3 months

Trial Locations

Locations (1)

Orbis Medical Center; 🇳🇱 Sittard, Netherlands