TY - JOUR
T1 - Effects of vitamin D3 in clinically isolated syndrome and healthy control participants
T2 - A double-blind randomised controlled trial
AU - O’Connell, Karen
AU - Sulaimani, Jamal
AU - Basdeo, Sharee A.
AU - Kinsella, Katie
AU - Jordan, Sinead
AU - Kenny, Orla
AU - Kelly, Siobhan B.
AU - Murphy, David
AU - Heffernan, Eric
AU - Killeen, Ronan P.
AU - Mulready, Keith
AU - MacMahon, Marguerite
AU - Brady, Jennifer J.
AU - McKenna, Carmel
AU - Muldowney, Ciaran
AU - Cassidy, Lorraine
AU - Walsh, Cathal
AU - O’Rourke, Killian
AU - Tubridy, Niall
AU - McGuigan, Chris
AU - Fletcher, Jean M.
AU - Hutchinson, Michael
N1 - Publisher Copyright:
© 2017, © The Author(s) 2017.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - Background: Lowserum vitamin D levels are associated with susceptibility to, and severity of, multiple sclerosis. High dose vitamin D has been proposed as a potential immunomodulator in multiple sclerosis. Objectives: We performed a single centre, investigator-led, exploratory, double-blind, randomised, placebo controlled, trial of vitamin D3 in clinically isolated syndrome and healthy control participants to assess its immunological effects. Secondary end-points included clinical and magnetic resonance imaging outcomes and safety. Methods: Clinically isolated syndrome patients and healthy control participants were randomised to: placebo, 5000 IU or 10,000 IU vitamin D3/day (Vigantol oil). Study duration was 24 weeks. Results: The trial did not meet its primary end point, with no difference in the frequency of pro-inflammatory CD4+ T cells (interleukin (IL)-17+/interferon (IFN)-γ+) seen. A higher level of disease freedom (67% versus 50%) was seen in those with serum 1,25 (OH) vitamin D levels>100 nmol/l but this did not reach significance. High dose vitamin D3 was well tolerated with no safety signal. Conclusions: High dose vitamin D3 over 24 weeks was well tolerated but without immunological, magnetic resonance imaging or clinical evidence of benefit. The hypothesised therapeutic effects in clinically isolated syndrome or multiple sclerosis patients may require longer periods of administration or may only be seen in patients treated with vitamin D3 as an adjunct to established disease modifying therapies.
AB - Background: Lowserum vitamin D levels are associated with susceptibility to, and severity of, multiple sclerosis. High dose vitamin D has been proposed as a potential immunomodulator in multiple sclerosis. Objectives: We performed a single centre, investigator-led, exploratory, double-blind, randomised, placebo controlled, trial of vitamin D3 in clinically isolated syndrome and healthy control participants to assess its immunological effects. Secondary end-points included clinical and magnetic resonance imaging outcomes and safety. Methods: Clinically isolated syndrome patients and healthy control participants were randomised to: placebo, 5000 IU or 10,000 IU vitamin D3/day (Vigantol oil). Study duration was 24 weeks. Results: The trial did not meet its primary end point, with no difference in the frequency of pro-inflammatory CD4+ T cells (interleukin (IL)-17+/interferon (IFN)-γ+) seen. A higher level of disease freedom (67% versus 50%) was seen in those with serum 1,25 (OH) vitamin D levels>100 nmol/l but this did not reach significance. High dose vitamin D3 was well tolerated with no safety signal. Conclusions: High dose vitamin D3 over 24 weeks was well tolerated but without immunological, magnetic resonance imaging or clinical evidence of benefit. The hypothesised therapeutic effects in clinically isolated syndrome or multiple sclerosis patients may require longer periods of administration or may only be seen in patients treated with vitamin D3 as an adjunct to established disease modifying therapies.
KW - cholecalciferol
KW - clinically isolated syndrome
KW - immunology
KW - Multiple sclerosis
KW - randomised controlled trial
KW - vitamin D
UR - http://www.scopus.com/inward/record.url?scp=85043463570&partnerID=8YFLogxK
U2 - 10.1177/2055217317727296
DO - 10.1177/2055217317727296
M3 - Article
AN - SCOPUS:85043463570
SN - 2055-2173
VL - 3
SP - 2055217317727296
JO - Multiple Sclerosis Journal - Experimental, Translational and Clinical
JF - Multiple Sclerosis Journal - Experimental, Translational and Clinical
IS - 3
ER -