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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG044271 | U.S. NIH Grant/Contract | View source |
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Funding was terminated, the study will not enroll any subjects
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplements Group | Experimental | Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily. |
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| Standard of Care Group | No Intervention | Standard of care treatment for vestibular function. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Lipoic Acid 300mg | Drug | A naturally occuring mitochondrial antioxidant |
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| Measure | Description | Time Frame |
|---|---|---|
| Slow Harmonic Acceleration | 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. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Step Velocity Test | Step velocity test involves sudden chair rotations and abrupt stops in both directions, which generate compensatory eye movements predominantly in response to the stimulated side. Abnormal findings during this test can suggest problems with the vestibular system, providing additional information about the affected side. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Perry, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
All collected deidentified IPD that underlie results in a publication
At study completion when the PI publishes in a peer review journal.
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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Two arm non-blinded controlled clinical trial. Subjects will be randomized 1: 1 either into the investigational antioxidant arm or the standard of care, no study drug arm.
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| Coenzyme Q10 200mg | Drug | A naturally occuring mitochondrial antioxidant |
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| Number of falls | A count of number of falls experienced | Baseline to 12 months |
| Tolerance of supplements | Number of adverse events experienced | Baseline to 12 months |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |