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Vestibular Function Using Mitochondrial Antioxidant Therapy

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05945160
Collaborator
National Institute on Aging (NIA) (NIH)
50
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alpha Lipoic Acid 300mg
  • Drug: Coenzyme Q10 200mg
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Alpha Lipoic Acid 300mg
A naturally occuring mitochondrial antioxidant
Other Names:
  • ALA

    • Drug: Coenzyme Q10 200mg
    A naturally occuring mitochondrial antioxidant
    Other Names:
  • CoQ10

    		•
    No Intervention: Standard of Care Group

    Standard of care treatment for vestibular function.

    Outcome Measures

    Primary Outcome Measures

    1. Slow Harmonic Acceleration [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.

    Secondary Outcome Measures

    1. Step Velocity Test [Baseline to 12 months]

      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.

    2. Number of falls [Baseline to 12 months]

      A count of number of falls experienced

    3. Tolerance of supplements [Baseline to 12 months]

      Number of adverse events experienced

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Community dwelling non-gender specific aged 65-90 years of age

    2. For female subjects, confirm that they are post-menopausal

    3. Diagnosed with vestibular dysfunction

    4. Able to provide informed consent

    5. Prepared to adhere to study drug regimen and attend all study visits

    Exclusion Criteria:

    1. Unable to provide informed consent

    2. Allergy/sensitivity to the study drugs or any of their ingredients

    3. Unable to adhere to study drug regimen or to attend study visits.

    4. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

    5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

    6. Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)

    7. Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.

    8. Participants who are undergoing treatment with theophylline.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Brian Perry, MD, University of Texas Health Science Center San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Perry, Professor/Clinical, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05945160
    Other Study ID Numbers:
    • HSC20230134H
    • 5P30AG044271
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brian Perry, Professor/Clinical, The University of Texas Health Science Center at San Antonio
    Alpha lipoic acid
    CoQ10
    Additional relevant MeSH terms:
    Vestibular Diseases
    Thioctic Acid
    Ubiquinone
    Coenzyme Q10

    Study Results

    No Results Posted as of Jul 14, 2023