Vestibular Function Using Mitochondrial Antioxidant Therapy

Vestibular Function Disorder Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05945160
• Other study ID #: HSC20230134H
• Secondary ID: 5P30AG044271
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Function Disorder

Intervention

Drug:
• Alpha Lipoic Acid 300mg
A naturally occuring mitochondrial antioxidant
• Coenzyme Q10 200mg
A naturally occuring mitochondrial antioxidant

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Number of falls	A count of number of falls experienced	Baseline to 12 months
Secondary	Tolerance of supplements	Number of adverse events experienced	Baseline to 12 months