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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940719
• Other study ID #: MUMC09T43
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: August 10, 2010
• Start date: August 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• vitamin D3
Oil-based solution, 1 dose of 500 microgram each day, during 3 months.

Locations

Country	Name	City	State
Netherlands	Orbis Medical Center	Sittard

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Orbis Medical Centre

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Smolders J, Damoiseaux J, Menheere P, Hupperts R. Vitamin D as an immune modulator in multiple sclerosis, a review. J Neuroimmunol. 2008 Feb;194(1-2):7-17. doi: 10.1016/j.jneuroim.2007.11.014. Epub 2008 Jan 4. Review. — View Citation

Smolders J, Menheere P, Kessels A, Damoiseaux J, Hupperts R. Association of vitamin D metabolite levels with relapse rate and disability in multiple sclerosis. Mult Scler. 2008 Nov;14(9):1220-4. doi: 10.1177/1352458508094399. Epub 2008 Jul 24. — View Citation

Smolders J, Menheere P, Thewissen M, Peelen E, Tervaert JW, Hupperts R, Damoiseaux J. Regulatory T cell function correlates with serum 25-hydroxyvitamin D, but not with 1,25-dihydroxyvitamin D, parathyroid hormone and calcium levels in patients with relapsing remitting multiple sclerosis. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):243-6. doi: 10.1016/j.jsbmb.2010.03.001. Epub 2010 Mar 6. — View Citation

Smolders J, Thewissen M, Peelen E, Menheere P, Tervaert JW, Damoiseaux J, Hupperts R. Vitamin D status is positively correlated with regulatory T cell function in patients with multiple sclerosis. PLoS One. 2009 Aug 13;4(8):e6635. doi: 10.1371/journal.pone.0006635. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell regulation		3 months	No
Secondary	serum 25-hydroxyvitamin D levels		3 months	No
Secondary	calcium metabolism		3 months	Yes