NCT00940719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

7 months

First QC Date

July 15, 2009

Last Update Submit

August 10, 2010

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisRegulatory T cell functionVitamin DVitamin D325-hydroxyvitamin D

Outcome Measures

Primary Outcomes (1)

  • T cell regulation

    3 months

Secondary Outcomes (2)

  • serum 25-hydroxyvitamin D levels

    3 months

  • calcium metabolism

    3 months

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Patients receive 1dd 500ug vitamin D3 for 3 months

Dietary Supplement: vitamin D3

Interventions

vitamin D3DIETARY_SUPPLEMENT

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

Also known as: Vigantol Oil (Merck)
Vitamin D3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsing Remitting MS (Revised MCDonald criteria 2005)
  • Age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orbis Medical Center

Sittard, 6130MD, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 18653736BACKGROUND

  • 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.

    PMID: 18177949BACKGROUND

  • 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.

    PMID: 19675671BACKGROUND

  • 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.

    PMID: 20211254BACKGROUND

  • 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.

    PMID: 21179201DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Raymond Hupperts, M.D., Ph.D.

    Orbis Medical Center Sittard, Maastricht Univeristy Medical Center Maastricht

    STUDY DIRECTOR

  • Joost Smolders, M.D.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 16, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations

NL(1)