Vestibular Function Using Mitochondrial Antioxidant Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vestibular Function Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alpha Lipoic Acid 300mg

Intervention Type DRUG

A naturally occuring mitochondrial antioxidant

Coenzyme Q10 200mg

Intervention Type DRUG

A naturally occuring mitochondrial antioxidant

Standard of Care Group

Standard of care treatment for vestibular function.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alpha Lipoic Acid 300mg

A naturally occuring mitochondrial antioxidant

Intervention Type DRUG

Coenzyme Q10 200mg

A naturally occuring mitochondrial antioxidant

Intervention Type DRUG

Other Intervention Names

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ALA CoQ10

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes