Safety and T Cell Modulating Effects of High Dose Vitamin D3 Supplementation in Multiple Sclerosis

PLoS ONE 5(12): e15235. doi:10.1371/journal.pone.0015235, Clinicaltrials.gov NCT00940719
Joost Smolders1,2,3*, Evelyn Peelen1,2,3, Mariëlle Thewissen2, Jan Willem Cohen Tervaert1,2,5, Paul Menheere4, Raymond Hupperts1,3, Jan Damoiseaux2,5
1 School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands,
2 Division of Clinical and Experimental Immunology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, The Netherlands,
3 Academic MS Center Limburg, Orbis Medical Center, Sittard, The Netherlands,
4 Department of Clinical Chemistry, Maastricht University Medical Center, Maastricht, The Netherlands,
5 Laboratory for Clinical Immunology, Maastricht University Medical Center, Maastricht, The Netherlands
j.smolders at mumc.nl

Background
A poor vitamin D status has been associated with a high disease activity of multiple sclerosis (MS). Recently, we described associations between vitamin D status and peripheral T cell characteristics in relapsing remitting MS (RRMS) patients. In the present study, we studied the effects of high dose vitamin D3 supplementation on safety and T cell related outcome measures.

Methodology/Principal Findings
Fifteen RRMS patients were supplemented with 20 000 IU/d vitamin D3 for 12 weeks. Vitamin D and calcium metabolism were carefully monitored, and T cell characteristics were studied by flowcytometry. All patients finished the protocol without side-effects, hypercalcaemia, or hypercalciuria. The median vitamin D status increased from 50 nmol/L (31–175) at week 0 to 380 nmol/L (151–535) at week 12 (P<0.001). During the study, 1 patient experienced an exacerbation of MS and was censored from the T cell analysis. The proportions of (naïve and memory) CD4+ Tregs remained unaffected. Although Treg suppressive function improved in several subjects, this effect was not significant in the total cohort (P = 0.143). An increased proportion of IL-10+ CD4+ T cells was found after supplementation (P = 0.021). Additionally, a decrease of the ratio between IFN-?+ and IL-4+ CD4+ T cells was observed (P = 0.035).

Conclusion/Significance
Twelve week supplementation of high dose vitamin D3 in RRMS patients was well tolerated and did not induce decompensation of calcium metabolism. The skewing towards an anti-inflammatory cytokine profile supports the evidence on vitamin D as an immune-modulator, and may be used as outcome measure for upcoming randomized placebo-controlled trials.
Trial Registration Clinicaltrials.gov NCT00940719
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No apparent problems with 152 ng/ml group average, with one individual having 214 ng/ml

PDF Shows

• More than half had decreased fatigue with vitamin D
• Relapse rate with vitamin D was only 0.27 per year vs previous 0.80 per year without vitamin D (that they know of)

See also VitaminDWiki

• Overview of MS and Vitamin D
• 10,000 IU vitamin D plus 1200 mg Calcium MS trial April 2010 - investigate if get too much Calcium, noticed that it reduced MS relapses
• All items in MS and Vitamin D has 119 items Feb 2012
• 300,000 IU vitamin D monthly may treat MS – May 2011 injection averaged to 10,000 IU daily