This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Orbis Medical Centre
Information provided by:
Maastricht University Medical Center Identifier:
First received: July 15, 2009
Last updated: August 10, 2010
Last verified: August 2010
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.

Condition Intervention
Multiple Sclerosis Dietary Supplement: vitamin D3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • T cell regulation [ Time Frame: 3 months ]

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

Estimated Enrollment: 15
Study Start Date: August 2009
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3
Patients receive 1dd 500ug vitamin D3 for 3 months
Dietary Supplement: vitamin D3
Oil-based solution, 1 dose of 500 microgram each day, during 3 months.
Other Name: Vigantol Oil (Merck)

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00940719

Orbis Medical Center
Sittard, Netherlands, 6130MD
Sponsors and Collaborators
Maastricht University Medical Center
Orbis Medical Centre
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. dr. Raymond Hupperts, M.D., Ph.D., Orbis Medical Center Sittard, Maastricht University Medical Center Maastricht Identifier: NCT00940719     History of Changes
Other Study ID Numbers: MUMC09T43
Study First Received: July 15, 2009
Last Updated: August 10, 2010

Keywords provided by Maastricht University Medical Center:
Multiple Sclerosis
Regulatory T cell function
Vitamin D
Vitamin D3
25-hydroxyvitamin D

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 19, 2017