A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Slow Harmonic Acceleration
研究概览
简要总结
To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
详细描述
The subjects will be divided into two groups, half will be given daily supplementation with ALA and CoQ-10. The second group will only receive standard of care treatment, with no study drug intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community dwelling non-gender specific aged 65-90 years of age
- •For female subjects, confirm that they are post-menopausal
- •Diagnosed with vestibular dysfunction
- •Able to provide informed consent
- •Prepared to adhere to study drug regimen and attend all study visits
排除标准
- •Unable to provide informed consent
- •Allergy/sensitivity to the study drugs or any of their ingredients
- •Unable to adhere to study drug regimen or to attend study visits.
- •Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)
- •Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.
- •Participants who are undergoing treatment with theophylline.
研究组 & 干预措施
Nutritional Supplements Group
Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.
干预措施: Alpha Lipoic Acid 300mg (Drug)
Nutritional Supplements Group
Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.
干预措施: Coenzyme Q10 200mg (Drug)
结局指标
主要结局
Slow Harmonic Acceleration
时间窗: Baseline to 12 months
Change in vestibular function using the slow harmonic acceleration rotating chair test to measure change, phase and time constant. The sinusoidal harmonic acceleration (SHA) test is a diagnostic procedure used to evaluate the vestibular system, which is responsible for maintaining balance. In the sinusoidal harmonic acceleration test, a person sits in a rotational chair that moves smoothly in controlled, rhythmic oscillations. These movements stimulate the vestibular system and induce eye movements that reflect dynamic vestibular function. Abnormal findings on the SHA test may suggest unilateral or bilateral vestibular dysfunction and provide insights into the status of central compensation for vestibular issues.
次要结局
- Tolerance of supplements(Baseline to 12 months)
- Step Velocity Test(Baseline to 12 months)
- Number of falls(Baseline to 12 months)