An initial, short-duration study of vitamin D versus an inactive thera
Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- N/A
What it measured
Main measures
1 Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participa
Immune response
Other measures (1)
1) To determine whether there is a dose response effect of supplementation using 4,667 IU and 9,333 IU of vitamin D versus placebo over four and six months on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants
Immune response
Who could take part
Early (CIS/RIS)
Show the full criteria
Inclusion criteria
Inclusion: a) Healthy volunteer participants. The healthy control subjects will be specifically recruited from and junior hospital doctors, nursing and administrative staff at St Vincent's University Hospital in the age range 25-40 years since the CIS/MS population will have a mean age of 30-32 years based on natural history data. The gender ratio of the control subjects will be 2:1: F: M since that is the ratio found in MS/CIS patients. Exclusion: a) Patients in whom any disease other than MS could explain their signs and symptoms.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome or early MS not treated with disease modifying therapies 2) healthy control participants
Papers
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History
Started
Feb 2012