Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial

Hdl Handle:
http://hdl.handle.net/10147/305334
Title:
Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial
Authors:
O’Connell, Karen; Kelly, Siobhan; Kinsella, Katie; Jordan, Sinead; Kenny, Orla; Murphy, David; Heffernan, Eric; O’Laoide, Risteard; O’Shea, Donal; McKenna, Carmel; Cassidy, Lorraine; Fletcher, Jean; Walsh, Cathal; Brady, Jennifer; McGuigan, Christopher; Tubridy, Niall; Hutchinson, Michael
Citation:
Trials. 2013 Aug 27;14(1):272
Journal:
Trials
Issue Date:
27-Aug-2013
URI:
http://dx.doi.org/10.1186/1745-6215-14-272; http://hdl.handle.net/10147/305334
Abstract:
Abstract Background There is increasing evidence linking vitamin D deficiency to both susceptibility to, and severity of, multiple sclerosis (MS). Patients with the clinically isolated syndrome represent the initial presentation of a demyelinating disorder, and those with asymptomatic lesions on magnetic resonance imaging (MRI) are at risk of progression to clinically definite MS. The aims of this study are to examine the immunologic effects of vitamin D in both healthy individuals and in patients with clinically isolated syndrome, and in the latter group the effects on disease progression assessed by MRI and clinical measures. Methods/Design This is a single-center double-blind randomized placebo-controlled clinical trial. The primary endpoint is the immunologic effects of two doses of vitamin D compared with placebo over 24 weeks in both healthy control participants and patients presenting with the clinically isolated syndrome. Healthy control participants (n = 39) and patients with clinically isolated syndrome (n = 45) will be randomized to one of three arms, namely 1) vitamin D 5,000 IU daily, 2) vitamin D 10,000 IU daily, or 3) placebo, and followed up for 24 weeks. In both patients and healthy control participants, the primary outcome will be immunologic measures of the frequency of CD4 T-cell subsets and cytokine responses in peripheral blood mononuclear cells, assessed at baseline, and after 16 and 24 weeks of treatment. Secondary endpoints, in the patients with clinically isolated syndrome, will be relapse activity, and the number of new T2 lesions and gadolinium-enhancing lesions assessed by MRI in the two vitamin D-treated groups compared with the placebo-treated group over the 24 weeks of the study. Trial registration EU Clinical Trials Register: EudraCT: 2012-000635-68. ClinicalTrials.gov identifier: NCT01728922
Language:
en
Keywords:
IMMUNE SYSTEM; VITAMIN SUPPLEMENT

Full metadata record

DC FieldValue Language
dc.contributor.authorO’Connell, Karenen_GB
dc.contributor.authorKelly, Siobhanen_GB
dc.contributor.authorKinsella, Katieen_GB
dc.contributor.authorJordan, Sineaden_GB
dc.contributor.authorKenny, Orlaen_GB
dc.contributor.authorMurphy, Daviden_GB
dc.contributor.authorHeffernan, Ericen_GB
dc.contributor.authorO’Laoide, Ristearden_GB
dc.contributor.authorO’Shea, Donalen_GB
dc.contributor.authorMcKenna, Carmelen_GB
dc.contributor.authorCassidy, Lorraineen_GB
dc.contributor.authorFletcher, Jeanen_GB
dc.contributor.authorWalsh, Cathalen_GB
dc.contributor.authorBrady, Jenniferen_GB
dc.contributor.authorMcGuigan, Christopheren_GB
dc.contributor.authorTubridy, Niallen_GB
dc.contributor.authorHutchinson, Michaelen_GB
dc.date.accessioned2013-11-13T14:49:45Z-
dc.date.available2013-11-13T14:49:45Z-
dc.date.issued2013-08-27-
dc.identifier.citationTrials. 2013 Aug 27;14(1):272en_GB
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-14-272-
dc.identifier.urihttp://hdl.handle.net/10147/305334-
dc.description.abstractAbstract Background There is increasing evidence linking vitamin D deficiency to both susceptibility to, and severity of, multiple sclerosis (MS). Patients with the clinically isolated syndrome represent the initial presentation of a demyelinating disorder, and those with asymptomatic lesions on magnetic resonance imaging (MRI) are at risk of progression to clinically definite MS. The aims of this study are to examine the immunologic effects of vitamin D in both healthy individuals and in patients with clinically isolated syndrome, and in the latter group the effects on disease progression assessed by MRI and clinical measures. Methods/Design This is a single-center double-blind randomized placebo-controlled clinical trial. The primary endpoint is the immunologic effects of two doses of vitamin D compared with placebo over 24 weeks in both healthy control participants and patients presenting with the clinically isolated syndrome. Healthy control participants (n = 39) and patients with clinically isolated syndrome (n = 45) will be randomized to one of three arms, namely 1) vitamin D 5,000 IU daily, 2) vitamin D 10,000 IU daily, or 3) placebo, and followed up for 24 weeks. In both patients and healthy control participants, the primary outcome will be immunologic measures of the frequency of CD4 T-cell subsets and cytokine responses in peripheral blood mononuclear cells, assessed at baseline, and after 16 and 24 weeks of treatment. Secondary endpoints, in the patients with clinically isolated syndrome, will be relapse activity, and the number of new T2 lesions and gadolinium-enhancing lesions assessed by MRI in the two vitamin D-treated groups compared with the placebo-treated group over the 24 weeks of the study. Trial registration EU Clinical Trials Register: EudraCT: 2012-000635-68. ClinicalTrials.gov identifier: NCT01728922-
dc.language.isoenen
dc.subjectIMMUNE SYSTEMen_GB
dc.subjectVITAMIN SUPPLEMENTen_GB
dc.titleDose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trialen_GB
dc.identifier.journalTrialsen_GB
dc.language.rfc3066en-
dc.rights.holderKaren O’Connell et al.; licensee BioMed Central Ltd.-
dc.description.statusPeer Reviewed-
dc.date.updated2013-11-13T10:28:35Z-
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