Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Lipoic Acid Levels
研究概览
简要总结
The purpose of this study is to learn about how the antioxidant, lipoic acid, works in the body and how it may help in the management of relapsing remitting and secondary progressive multiple sclerosis. This study will compare how subject's and healthy volunteers bodies absorb and break down the supplement. This information may help in developing new therapies.
详细描述
Subjects (healthy control, relapsing remitting MS and secondary progressive MS) will be recruited through patients of investigators at Portland VA Medical Center (PVAMC), Oregon Health & Science University (OHSU), and the community using flyers and word of mouth.
The following will occur during screening:
- Medical History Questionnaire to include questions about drug and alcohol use
- Self Administered Expanded Disability Status Scale (EDSS) Questionnaire (MS participants only)
- Vital Signs (heart rate, respiratory rate, blood pressure) will be measured and recorded
- Physical Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Neurological Exam (MS participants only unless necessary, based on the Medical History Questionnaire or vital signs, to ensure participant safety)
- Weight
- Urine pregnancy test, if applicable
- Anemia testing by finger stick (approximately 1 drop)
The rest of the study involves
- Blood draws before lipoic acid is given, 1 hour, 2 hours, 3 hours, 4 hours, 24 and 48 hours after LA is given (3 ½ tablespoons)
- Subjects will receive breakfast before they take LA
- Subjects will take 4 - 300 mg capsules of lipoic acid (LA) for a total of 1200mg with about 1 cup of water
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Lipoic Acid Levels
时间窗: 48 hour
Plasma concentration of LA
cAMP Levels
时间窗: 4 hours
次要结局
- RANTES Levels(48 hour)
研究者
Daniel Carr
Research Career Scientist
Portland VA Medical Center