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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00940719
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 11, 2010
Sponsor:
Collaborator:
Orbis Medical Centre
Information provided by:
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE July 15, 2009
First Posted Date  ICMJE July 16, 2009
Last Update Posted Date August 11, 2010
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
T cell regulation [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
  • serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ]
  • calcium metabolism [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Dietary Supplement: vitamin D3
Oil-based solution, 1 dose of 500 microgram each day, during 3 months.
Other Name: Vigantol Oil (Merck)
Study Arms  ICMJE Experimental: Vitamin D3
Patients receive 1dd 500ug vitamin D3 for 3 months
Intervention: Dietary Supplement: vitamin D3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 15, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00940719
Other Study ID Numbers  ICMJE MUMC09T43
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. dr. Raymond Hupperts, M.D., Ph.D., Orbis Medical Center Sittard, Maastricht University Medical Center Maastricht
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Orbis Medical Centre
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP