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

This study has been completed.
Sponsor:
Collaborator:
Orbis Medical Centre
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00940719
First received: July 15, 2009
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • T cell regulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • calcium metabolism [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940719

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

Publications:

Responsible Party: Prof. dr. Raymond Hupperts, M.D., Ph.D., Orbis Medical Center Sittard, Maastricht University Medical Center Maastricht
ClinicalTrials.gov Identifier: NCT00940719     History of Changes
Other Study ID Numbers: MUMC09T43
Study First Received: July 15, 2009
Last Updated: August 10, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013