Vitamin D3 Supplementation and the T Cell Compartment in Multiple Scle
The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
T cell regulation
3 months
Other measures (2)
serum 25-hydroxyvitamin D levels
3 months
calcium metabolism
3 months
Who could take part
Relapsing MS · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Background
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.Background
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.Background
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.Background
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.
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History
Started
Aug 2009
Main results due
Mar 2010
Finished
Jul 2010