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

• ClinicalTrials.gov Identifier: NCT00940719
• Recruitment Status: Completed
• First Posted: July 16, 2009
• Last Update Posted: August 11, 2010
• Sponsor: Maastricht University Medical Center
• Collaborator: Orbis Medical Centre
• Information provided by: Maastricht University Medical Center

Tracking Information

• First Submitted Date: July 15, 2009
• First Posted Date: July 16, 2009
• Last Update Posted Date: August 11, 2010
• Study Start Date: August 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 15, 2009): T cell regulation [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 15, 2009)

• serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ]
• calcium metabolism [ Time Frame: 3 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)
• Official Title: The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Multiple Sclerosis

Intervention

Dietary Supplement: vitamin D3

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

Other Name: Vigantol Oil (Merck)

Study Arms

Experimental: Vitamin D3

Patients receive 1dd 500ug vitamin D3 for 3 months

Intervention: Dietary Supplement: vitamin D3

Publications *

• 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.
• 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.
• 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.
• 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.
• Smolders J, Peelen E, Thewissen M, Cohen Tervaert JW, Menheere P, Hupperts R, Damoiseaux J. Safety and T cell modulating effects of high dose vitamin D3 supplementation in multiple sclerosis. PLoS One. 2010 Dec 13;5(12):e15235. doi: 10.1371/journal.pone.0015235.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 15, 2009): 15
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00940719
• Other Study ID Numbers: MUMC09T43
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. dr. Raymond Hupperts, M.D., Ph.D., Orbis Medical Center Sittard, Maastricht University Medical Center Maastricht
• Study Sponsor: Maastricht University Medical Center
• Collaborators: Orbis Medical Centre

Investigators

• Study Director: Raymond Hupperts, M.D., Ph.D.; Orbis Medical Center Sittard, Maastricht Univeristy Medical Center Maastricht
• Principal Investigator: Joost Smolders, M.D.; Maastricht University Medical Center

• PRS Account: Maastricht University Medical Center
• Verification Date: August 2010