Back to resultsVestibular Function Using Mitochondrial Antioxidant Therapy
Primary Purpose
Vestibular Function Disorder
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alpha Lipoic Acid 300mg
Coenzyme Q10 200mg
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Function Disorder focused on measuring Alpha lipoic acid, CoQ10
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional Supplements Group
Standard of Care Group
Arm Description
Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.
Standard of care treatment for vestibular function.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of falls
A count of number of falls experienced
Tolerance of supplements
Number of adverse events experienced
Full Information
NCT ID
NCT05945160
First Posted
July 5, 2023
Last Updated
October 16, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05945160
Brief Title
Vestibular Function Using Mitochondrial Antioxidant Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was terminated, the study will not enroll any subjects
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Function Disorder
Keywords
Alpha lipoic acid, CoQ10
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Supplements Group
Arm Type
Experimental
Arm Description
Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Standard of care treatment for vestibular function.
Intervention Type
Drug
Intervention Name(s)
Alpha Lipoic Acid 300mg
Other Intervention Name(s)
ALA
Intervention Description
A naturally occuring mitochondrial antioxidant
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10 200mg
Other Intervention Name(s)
CoQ10
Intervention Description
A naturally occuring mitochondrial antioxidant
Primary Outcome Measure Information:
Title
Slow Harmonic Acceleration
Description
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.
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Step Velocity Test
Description
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.
Time Frame
Baseline to 12 months
Title
Number of falls
Description
A count of number of falls experienced
Time Frame
Baseline to 12 months
Title
Tolerance of supplements
Description
Number of adverse events experienced
Time Frame
Baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Perry, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected deidentified IPD that underlie results in a publication
IPD Sharing Time Frame
At study completion when the PI publishes in a peer review journal.
Learn more about this trial
Vestibular Function Using Mitochondrial Antioxidant Therapy
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