EUCTR2012-000635-68-IE进行中（未招募）1 期
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 - N/A
niversity College Dublin0 个研究点开始时间: 2012年2月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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