EUCTR2011-002785-20-DE进行中（未招募）1 期
Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis - EVIDIMS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Informed consent
- •Age between 18 and 65 at randomization
- •Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
- •EDSS = 6,0
- •Stable immunomodulatory treatment for at least 6 months
- •Sufficient birth control (Pearl-Index <1) and negative pregnancy test at screening/randomization
- •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 77
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Any other MS-course than RRMS
- •Treatment with vitamin D within three months prior to randomization
- •Any condition that could interfere with MRI or other study related investigation
- •Intolerability of Gd-DTPA
- •Hypercalcaemia and/or hypercalcuria
- •Presence or history of nephrolithiasis
- •Clinically relevant dysfunction of kidney (creatinine-clearance (Cockroft-Gault) Cl < 110ml/min (male) or Cl < 95ml/min (female)
- •Clinically relevant gastrointestinal, hepatological, pulmonary, cardiological, hematological, infectious or CNS-disease (other than MS) disease
- •Allergy against components of study drug
- •Treatment with hydrochlorthiazide, digitoxin, digoxin, phenytoin, barbiturates
- •Clinically relevant drug- or alcohol abuse
- •Pregnancy or lactation period
- •Participation in any clinical study within 3 months before or at any time during study
- •Treatment within 6 months before randomization with any other immunomodulatory substance than IFN-ß, glatiramer acetate or intravenous methylprednisolone
- •Any medical, psychiatric or other condition that could interfere with the patient’s ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution
研究者
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