Vestibular Function Using Mitochondrial Antioxidant Therapy

October 16, 2023 updated by: The University of Texas Health Science Center at San Antonio

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

To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months
Number of falls
Time Frame: Baseline to 12 months
A count of number of falls experienced
Baseline to 12 months
Tolerance of supplements
Time Frame: Baseline to 12 months
Number of adverse events experienced
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Aging (NIA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20230134H
  • 5P30AG044271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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