CISAVID
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ergocalciferol
Vitamin D receptor agonist
Placebo or sham
- Placebo
What it measured
Main measures
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.
This outcome measure will be assessed at baseline and at 24 weeks.
Immune response
Other measures (3)
The number of new T2 and gadolinium enhancing lesions compared to baseline amongst the study group.
Baseline and 24 weeks
MRI lesionsRelapse occurrence in the CIS patients during 24 weeks of the trial
At each clinic visit or as the need arises.
RelapsesThe 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).
At 24 weeks.
RelapsesMRI lesions
Who could take part
Early (CIS/RIS) · 18 to 55
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). * CIS: Patients with a clinically isolated syndrome with onset relapse within the previous three months and two or more than two asymptomatic T2 lesions on MRI brain scan. * Aged 18-55yrs. * Not receiving any disease modifying therapy. Exclusion Criteria: * Patients in whom any disease other than demyelination could explain their signs and symptoms. * Participants with known disease of the parathyroids, a history of vitamin D intolerance, sarcoidosis, a history of hypercalcaemia of any cause. * Participants with a baseline abnormality in serum urea, creatinine, calcium, parathormone. * Participants on thiazide diuretics (hypercalcaemia risk). * Patients with occurrence of a relapse less than six weeks prior to entry to study. * Previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months. * Any previous treatment with mitoxantrone or other immunosuppressant. * Participants already taking supplemental vitamin D.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
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History
Started
Nov 2012
Main results due
Jun 2015
Finished
Jun 2016
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