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Vestibular Function Using Mitochondrial Antioxidant Therapy

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ClinicalTrials.gov Identifier: NCT05945160
Recruitment Status : Withdrawn (Funding was terminated, the study will not enroll any subjects)
First Posted : July 14, 2023
Last Update Posted : October 18, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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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
Vestibular Function Disorder 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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.
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
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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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 Name: ALA

Drug: Coenzyme Q10 200mg
A naturally occuring mitochondrial antioxidant
Other Name: CoQ10
No Intervention: Standard of Care Group
Standard of care treatment for vestibular function.


Outcome Measures
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Primary Outcome Measures :
  1. Slow Harmonic Acceleration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 12 months ]
    A count of number of falls experienced

  3. Tolerance of supplements [ Time Frame: Baseline to 12 months ]
    Number of adverse events experienced


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945160


Locations
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United States, Texas
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
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Principal Investigator: Brian Perry, MD University of Texas Health Science Center San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT05945160    
Other Study ID Numbers: HSC20230134H
5P30AG044271 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: October 18, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected deidentified IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At study completion when the PI publishes in a peer review journal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Alpha lipoic acid
CoQ10
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Thioctic Acid
Ubiquinone
Coenzyme Q10
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients