Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of oral tolerance between R-LA and racemic LA
研究概览
简要总结
This is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: R form and racemic form.
详细描述
This three-week double-blind crossover trial will compare two different forms of lipoic acid (LA). Every participant will take one week of daily oral 600mg R LA, have a one week washout period without LA, and take one week of daily oral 1200mg racemic LA. The order of LA type will be determined by randomization. Blood analyses will be performed to determine which form is better absorbed and a side effects questionnaire will be completed at each visit in order to determine which form is better tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Progressive Multiple Sclerosis
- •18 years of age or older
- •Able to give informed consent and adhere to the study activities
- •Able to swallow large oral capsules
排除标准
- •Clinical Multiple Sclerosis relapse in the prior 1 year
- •Oral or IV steroids in the prior 3 months
- •Have taken LA in last 30 days
- •Clinically significant kidney disease as determined by the PI including, but not limited to, major kidney disease diagnoses, abnormal laboratory values related to renal function, or other related conditions
- •Insulin-dependent diabetes
- •Other significant ongoing medical illness that may interfere with study procedures
- •Taking oral anticoagulants (e.g. Coumadin). Aspirin, clopidogrel, and dipyridamole are acceptable to take
- •Pregnant or breast-feeding
- •Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
Group A
Group A will receive racemic lipoic acid first and R-lipoic acid second
干预措施: Alpha Lipoic Acid (Drug)
Group B
Group B will receive R- lipoic acid first and racemic lipoic acid second
干预措施: Alpha Lipoic Acid (Drug)
结局指标
主要结局
Comparison of oral tolerance between R-LA and racemic LA
时间窗: Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.
Oral tolerance will be determined by the completion of a modified Monitoring of Side Effects Scale at each study visit. This scale asks the participant to rate the following side effects: abdominal pain, appetite: decreased, appetite: increased, constipation, diarrhea, flatulence, nausea/vomiting, taste abnormality (metallic, etc.), thirst: increased, thirst: decreased, and weight: increased. Each side effect will be rated on severity. 0 - the lowest possible score represents "not present". 4 - the highest possible score represents "severe". The relative change in total tolerance score will be compared between R-LA and racemic LA.
Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA
时间窗: Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.
Serum bioavailability, as measured by Area Under the Curve (0-infinity) will be compared between R-LA and racemic LA by obtaining concentration values at times 0, 60, 90, 120, 180, and 240 minutes after ingestion of LA dose on the first (visits 1 and 3) and last doses (visits 2 and 4) of each LA form.
次要结局
未报告次要终点
研究者
Rebecca Spain
Principal Investigator
Oregon Health and Science University