Vestibular Function Using Mitochondrial Antioxidant Therapy

The University of Texas System (UT)

Status and phase: Withdrawn; Early Phase 1

Conditions: Vestibular Function Disorder

Treatments: Drug: Alpha Lipoic Acid 300mg; Drug: Coenzyme Q10 200mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05945160

HSC20230134H

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

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nutritional Supplements Group

Experimental group

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.

Treatment:

Drug: Coenzyme Q10 200mg

Drug: Alpha Lipoic Acid 300mg

Standard of Care Group

No Intervention group

Description:

Standard of care treatment for vestibular function.