Vestibular Function DisorderEarly Phase 1NCT05945160
Vestibular Function Using Mitochondrial Antioxidant Therapy
A Early Phase 1 study testing Alpha Lipoic Acid 300mg and Coenzyme Q10 200mg in people with Vestibular Function Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Disorder
- What is being tested?
- Alpha Lipoic Acid 300mg and Coenzyme Q10 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community dwelling non-gender specific aged 65-90 years of age
- For female subjects, confirm that they are post-menopausal
- Diagnosed with vestibular dysfunction
- Able to provide informed consent
- Prepared to adhere to study drug regimen and attend all study visits
Who cannot join
- Unable to provide informed consent
- Allergy/sensitivity to the study drugs or any of their ingredients
- Unable to adhere to study drug regimen or to attend study visits.
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)
- Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.
- Participants who are undergoing treatment with theophylline.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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
To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
Read the 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.
- Conditions
- Vestibular Function Disorder
- Being tested
- Alpha Lipoic Acid 300mg, Coenzyme Q10 200mg
- Keywords
- Alpha lipoic acid, CoQ10
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid 300mgDrug
Also called ALA
A naturally occuring mitochondrial antioxidant
Coenzyme Q10 200mgDrug
Also called CoQ10
A naturally occuring mitochondrial antioxidant
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplements Group | Experimental | Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily. Receives: Drug: Alpha Lipoic Acid 300mg; Drug: Coenzyme Q10 200mg |
| Standard of Care Group | No intervention | Standard of care treatment for vestibular function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (3)
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.
Measured: Baseline to 12 months
Number of falls
A count of number of falls experienced
Measured: Baseline to 12 months
Tolerance of supplements
Number of adverse events experienced
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startJan 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Funding was terminated, the study will not enroll any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Function DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Brian Perry, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945160
- Sponsor's protocol ID
- HSC20230134H
- Other IDs
- 5P30AG044271
- Status last verified
- Oct 2023
- First submitted
- 5 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected deidentified IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05945160
- Acronym / sponsor ID
- HSC20230134H
- Conditions
- Vestibular Function Disorder
- Keywords
- Alpha lipoic acid, CoQ10
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was terminated, the study will not enroll any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplements Group | Experimental | Drug: Alpha Lipoic Acid 300mg, Drug: Coenzyme Q10 200mgAlpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily. |
| Standard of Care Group | No intervention | –Standard of care treatment for vestibular function. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Community dwelling non-gender specific aged 65-90 years of age
- For female subjects, confirm that they are post-menopausal
- Diagnosed with vestibular dysfunction
- Able to provide informed consent
- Prepared to adhere to study drug regimen and attend all study visits
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Allergy/sensitivity to the study drugs or any of their ingredients
- Unable to adhere to study drug regimen or to attend study visits.
- Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic Acid 300mgAlso: ALAA naturally occuring mitochondrial antioxidant | Drug | Nutritional Supplements Group |
| Coenzyme Q10 200mgAlso: CoQ10A naturally occuring mitochondrial antioxidant | Drug | Nutritional Supplements Group |
Primary outcome
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.
3 secondary outcomes
Step Velocity Test
Time frame: Baseline to 12 months
Number of falls
Time frame: Baseline to 12 months
Tolerance of supplements
Time frame: Baseline to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. All collected deidentified IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Perry, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alpha Lipoic Acid 300mg and Coenzyme Q10 200mg in people with Vestibular Function Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow Harmonic Acceleration (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.