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OpenTrials
Completed

NCT Number: NCT00940719

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orbis Medical Center

Sittard, 6130MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

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

Other names: Vigantol Oil (Merck)

Primary outcomes

  1. T cell regulation

    Time frame: 3 months

Secondary outcomes

  1. serum 25-hydroxyvitamin D levels

    Time frame: 3 months

  2. calcium metabolism

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Orbis Medical Centre

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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