An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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.
b)Patients (n=45) with a clinically isolated syndrome and two or more than two T2 lesions on MRI brain scan or relapsing-remitting MS (McDonald’s criteria) within 5 years of onset, aged 18-55yrs
and not receiving any disease modifying therapy.
c)Although vitamin D has no effect on pregnancy, pregnancy affects MS activity and immunological measures, thus female CIS/MS patients and control participants will be requested to avoid becoming pregnant during the study.
d)Written informed consent from all participants (patients and healthy volunteers) after they have read the participant information leaflet.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Patients in whom any disease other than MS could explain their signs and symptoms.
b)Patients with known disease of the parathyroids, a history of vitamin D intolerance, sarcoidosis, a history of hypercalcaemia of any cause.
c)Patients with a baseline abnormality in serum urea, creatinine, calcium, parathormone.
d)Patients on thiazide diuretics (hypercalcaemia risk).
e)Occurrence of a relapse less than six weeks prior to entry to study.
f)Previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months.
g)Any previous treatment with mitoxantrone or other immunosuppressant.
h)Patients or controls already on supplemental vitamin D.