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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940719
Enrollment
15
Registered
2009-07-16
Start date
2009-08-31
Completion date
2010-07-31
Last updated
2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Regulatory T cell function, Vitamin D, Vitamin D3, 25-hydroxyvitamin D

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.

Interventions

DIETARY_SUPPLEMENTvitamin D3

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

Sponsors

Orbis Medical Centre
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
T cell regulation3 months

Secondary

MeasureTime frame
serum 25-hydroxyvitamin D levels3 months
calcium metabolism3 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026