A Phase 1/2 interventional study of 5000IU vitamin D and 10000IU vitamin D in Clinically Isolated Syndrome and Multiple Sclerosis, sponsored by University College Dublin. Completed at 1 site in Ireland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-03.
Sponsored by University College Dublin · Phase 1/2, Interventional, and Treatment
The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used
Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 5,000 IU daily b) 10,000 IU daily compared to c) placebo a 24 weeks period on the change from baseline in frequency of CD4 T cell subsets and cytokine responses by peripheral blood mononuclear cells in 1) patients with the clinically isolated syndrome. 2) healthy control participants.
Secondary endpoints:
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 64 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University College Dublin is the lead sponsor of 108 studies on the registry; 31 are open to participants now.
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Inclusion Criteria: To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2).
Exclusion Criteria:
13 healthy controls will be administered 5,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.
Dietary Supplement: 5000IU vitamin D
13 healthy controls will be administered 10,000 IU vitamin D. Primary outcome and safety outcome measures will be assessed.
Dietary Supplement: 10000IU vitamin D
15 patients will be administered placebo and all outcome measures will be assessed.
Other: Placebo
15 patients will be administered 5,000 IU vitamin D and all outcomes will be assessed.
Dietary Supplement: 5000IU vitamin D
15 patients will be administered 10,000 IU of vitamin D and all outcome measures assessed.
Dietary Supplement: 10000IU vitamin D
13 control participants who will be administered placebo. These will be assessed for the primary outcome and safety outcomes only.
Other: Placebo
Vigantol Oil
Also known as: Vigantol Oil
Vigantol Oil
Also known as: Vigantol Oil
Placebo Oil
Also known as: Placebo Oil
The effects of two doses of vitamin D and placebo therapy on the change in the frequency of CD4 T cell subsets and cytokine responses of PBMC over 24 weeks of therapy from baseline.
A number of measures will be examined in particular IL-10 production and the frequency of Th17 cells.
Time frame: This outcome measure will be assessed at baseline and at 24 weeks.
The number of new T2 and gadolinium enhancing lesions compared to baseline amongst the study group.
The MRI out-come measure will assess the a) number of Gadolinium enhancing lesions b) the number of new and enlarging T2 lesions c) the combined unique lesion count (new and enlarging T2 lesions plus Gadolinium enhancing lesions) after 24 weeks of therapy in the three arms, 5000IU, 10,000IU vitamin D and placebo . Mean and median new T2 and gadolinium-enhancing lesions at 24 weeks (end of the trial) will be compared for each treatment allocation group. In addition the mean and median number of new T2 lesions plus gadolinium enhancing lesions in all the CIS patients on vitamin D will be compared to the mean and median in the placebo group.
Time frame: Baseline and 24 weeks
Relapse occurrence in the CIS patients during 24 weeks of the trial
Relapse occurrence in the CIS patients during 24 weeks of the trial;(i) annualised relapse rates (ARR), (ii) percentage of patients free from relapses and (iii) time to first relapse will be compared for each treatment allocation group. In addition the same relapse measures will be applied to both vitamin D treated groups combined and compared to those in the placebo group.
Time frame: At each clinic visit or as the need arises.
The percentage of CIS patients in each treatment arm free from any evidence of disease activity (No relapses, no new T2 lesions, no gadolinium enhancing lesions).
Time frame: At 24 weeks.
Serum calcium
a measure of calcium homeostasis
Time frame: Every 4 weeks for 24 weeks
Number of participants with adverse events as a measure of safety and tolerability of vitamin D in doses of 5,000IU and 10,000IU daily
Time frame: four weekly assessments over 24 weeks
serum urea
a measure of renal function
Time frame: 4 weekly over 24 weeks
serum creatinine
a measure of renal function
Time frame: 4 weekly over 24 weeks
serum 25(OH)D levels
a measure of response to oral dosing and adherence to therapy.
Time frame: 4 weekly over 24 weeks
serum parathormone (iPTH)
a measure of parathyroid function
Time frame: 4 weekly over 24 weeks
Plan to share: Yes — all demographic details and outcome measures may be obtained directly from the PI by e-mail
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University College Dublin