TinnitusPhase 2NCT04105426
A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
A Phase 2 study testing Antioxidants in people with Tinnitus, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to assess the effectiveness of antioxidant supplementation in idiopathic tinnitus patients. To investigate this, a double-blind, randomized, and placebo-controlled clinical trial was conducted to assess the impact of a multivitamin-multimineral supplement with phytochemicals combined with… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Antioxidants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2019to 25 May 2019
- Phase
- Phase 2
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-75 years old
- Unilateral or bilateral chronic idiopathic persistent tinnitus of at least 6 months' duration
- Tinnitus Handicap Inventory score rated ≥ 4 at baseline
- With a normal audiogram or up to medium-grade neurosensory hearing loss.
- Tinnitus maskable (by noise masking) with noise at least 5 decibel
- Childbearing age with a negative pregnancy test at eligibility and baseline assessment
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- Stable medication during the whole period of the 3-month intervention
- Willing and able to attend the on-study visits
- Able to read and understand the relevant study documents and rating scales and follow investigator instructions during audiologic measurements
Who cannot join
- Tinnitus following acute acoustic trauma, sudden deafness or traumatic head or neck injury
- Intermittent tinnitus
- Meniere's Disease, otosclerosis, acute or chronic otitis media
- Head and neck radiotherapy
- Active GI disease; active malignant diseases; autoimmune diseases; cardiovascular disease; renal or hepatic disorders; haemorrhagic diathesis
- Intake of anticoagulants; ototoxic medications; tinnitus-inducing medication (e.g. aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin or quinine)
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- Psychiatric disorders
- Unregulated diabetes mellitus, hypertension or thyroid disease
- Alcohol or drug abuse
- Vitamin or inorganic supplements, vegan or macrobiotic diet before and during the trial
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
Greece1 site
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
Athens
About this study
Official title: A Phase-II Clinical Trial on the Effectiveness of Antioxidant Supplementation in Idiopathic Tinnitus Patients
The purpose of this study is to assess the effectiveness of antioxidant supplementation in idiopathic tinnitus patients.
To investigate this, a double-blind, randomized, and placebo-controlled clinical trial was conducted to assess the impact of a multivitamin-multimineral supplement with phytochemicals combined with a-lipoic acid supplements on serum oxidative stress, serum antioxidant capacity and tinnitus parameters in patients with idiopathic tinnitus.
Read more
Subjective, idiopathic, non-pulsatile tinnitus ("tinnitus") is perception of sound without the presence of an external acoustic stimulus. Causes of idiopathic tinnitus remain unknown and the pathological mechanisms are not fully understood. Currently, effective therapies for tinnitus remain limited. Previous research has demonstrated that oxidative stress is possibly involved in the pathogenesis of idiopathic tinnitus and some studies have shown beneficial effects of antioxidant therapy in tinnitus patients. Moreover, many studies have shown the beneficial effect of antioxidant supplementation on the reduction of oxidative stress and the increase of endogenous antioxidant enzymes and antioxidant capacity.
Seventy patients with idiopathic tinnitus were enrolled based on certain inclusion and exclusion criteria. Subsequently, they were informed regarding the aims, methods, anticipated benefits, and potential hazards of the study, and were provided with the information leaflet of the study. Each patient who agreed to take part in the study, signed an informed consent form, a copy of which was given to them.
Participants were allocated to either antioxidant or placebo group. Randomisation was conducted by someone who was not involved in the study and blinding was strictly maintained to researchers and participants.
The antioxidant group received one multivitamin and multimineral tablet with grape seed extract once a day together with one tablet of alpha-lipoic acid twice a day, whereas the placebo group received identical placebo tablets. Supplements were kindly donated by Lamberts. The intervention lasted 3 months. Both groups kept their usual medical treatment and their diet and exercise habits stable during the intervention.
Patients were assessed after randomisation according to the following tools:
- Medical history
- Audiometric and Tinnitus assessment: Basic audiometric tests, pitch match, loudness match, minimum masking level (MML)
- Tinnitus questionnaires: Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI) and Visual Analogue Scale (VAS)
- anthropometrics: body weight , height, Body Mass Index, waist and hip circumferences
- Nutrition and physical activity evaluation
- Adherence to the Mediterranean dietary pattern (MedDietScore)
- Psychological assessment
- Biochemical measurements: Complete blood count, lipid profile, glucose, electrolytes, liver enzymes, thyroid hormones
- Vitamin laboratory tests
- Oxidative stress assessment in serum samples: Total Antioxidant Capacity (TAC), Superoxide Dismutase (SOD) activity and Oxidized LDL are quantified.
Compliance and any side effects were checked with a weekly telephone contact with the patients. The consumption of tablets was checked with a diary completed by patients. At the end of the intervention, all baseline parameters were assessed.
- Conditions
- Tinnitus
- Being tested
- Antioxidants, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantsDietary supplement
one multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months.
PlaceboDietary supplement
one placebo tablet three times per day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Antioxidants | Active comparator | This arm of patients received one multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months. Receives: Dietary Supplement: Antioxidants |
| Placebo | Placebo comparator | This arm of patients received placebo for 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus loudness (in decibel) assessed by loudness matching test
Mean Change from Baseline in Tinnitus loudness at three months assessed by Loudness matching audiometric test
Measured: Change in tinnitus loudness was assessed at 3 months from baseline in tinnitus patients
Tinnitus Handicap Inventory Questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Mean Change from Baseline in Tinnitus Handicap Inventory Questionnaire at three months
Measured: Change in Tinnitus Handicap Inventory score was assessed at 3 months from baseline in tinnitus patients
Secondary outcomes (8)
Tinnitus frequency (in Hz) assessed by pitch match test
Mean Change from Baseline in Tinnitus frequency at three months
Measured: Change in Tinnitus frequency was assessed at 3 months from baseline in tinnitus patients
Tinnitus Functional Index questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Mean Change from Baseline in Tinnitus Functional Index score at three months
Measured: Change in Tinnitus Functional Index score was assessed at 3 months from baseline in tinnitus patients
serum Total Antioxidant Capacity (mM)
Mean Change from Baseline in Serum Total Antioxidant Capacity at three months
Measured: Change in Serum Total Antioxidant Capacity was assessed at 3 months from baseline in tinnitus patients
Vitamins B12, E, C, B2, B1, B6 and folic acid in blood
Mean Change from Baseline in vitamin levels at three months
Measured: Change in vitamin levels were assessed at 3 months from baseline in tinnitus patients
Tinnitus Minimum Masking Level (in decibel)
Mean Change from Baseline in Tinnitus Minimum Masking Level at three months
Measured: Change in Tinnitus Minimum Masking Level was assessed at 3 months from baseline in tinnitus patients
Visual Analogue Scale Score (ranging from 0 to 10) which assesses tinnitus annoyance
Mean Change from Baseline in Visual Analogue Scale Score at three months
Measured: Change in Visual Analogue Scale Score was assessed at 3 months from baseline in tinnitus patients
serum Superoxide Dismutase (U/ml)
Mean Change from Baseline in serum Superoxide Dismutase at three months
Measured: Change in serum Superoxide Dismutase was assessed at 3 months from baseline in tinnitus patients
serum Oxidized LDL (ng/ml)
Mean Change from Baseline in serum Oxidized LDL at three months
Measured: Change in serum Oxidized LDL was assessed at 3 months from baseline in tinnitus patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start10 Jan 2019
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Petridou, National and Kapodistrian University of Athens
- Investigators
- Ioannis Xenelis, Professor, Study director, General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105426
- Sponsor's protocol ID
- 4354
- Status last verified
- Nov 2019
- First submitted
- 23 Sep 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II Clinical Trial on the Effectiveness of Antioxidant Supplementation in Idiopathic Tinnitus Patients
- ClinicalTrials.gov ID
- NCT04105426
- Acronym / sponsor ID
- 4354
- Conditions
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 26 Sep 2019 (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.
The purpose of this study is to assess the effectiveness of antioxidant supplementation in idiopathic tinnitus patients.
To investigate this, a double-blind, randomized, and placebo-controlled clinical trial was conducted to assess the impact of a multivitamin-multimineral supplement with phytochemicals combined with a-lipoic acid supplements on serum oxidative stress, serum antioxidant capacity and tinnitus parameters in patients with idiopathic tinnitus.
Subjective, idiopathic, non-pulsatile tinnitus ("tinnitus") is perception of sound without the presence of an external acoustic stimulus. Causes of idiopathic tinnitus remain unknown and the pathological mechanisms are not fully understood. Currently, effective therapies for tinnitus remain limited. Previous research has demonstrated that oxidative stress is possibly involved in the pathogenesis of idiopathic tinnitus and some studies have shown beneficial effects of antioxidant therapy in tinnitus patients. Moreover, many studies have shown the beneficial effect of antioxidant supplementation on the reduction of oxidative stress and the increase of endogenous antioxidant enzymes and antioxidant capacity.
Seventy patients with idiopathic tinnitus were enrolled based on certain inclusion and exclusion criteria. Subsequently, they were informed regarding the aims, methods, anticipated benefits, and potential hazards of the study, and were provided with the information leaflet of the study. Each patient who agreed to take part in the study, signed an informed consent form, a copy of which was given to them.
Participants were allocated to either antioxidant or placebo group. Randomisation was conducted by someone who was not involved in the study and blinding was strictly maintained to researchers and participants.
The antioxidant group received one multivitamin and multimineral tablet with grape seed extract once a day together with one tablet of alpha-lipoic acid twice a day, whereas the placebo group received identical placebo tablets. Supplements were kindly donated by Lamberts. The intervention lasted 3 months. Both groups kept their usual medical treatment and their diet and exercise habits stable during the intervention.
Patients were assessed after randomisation according to the following tools:
- Medical history
- Audiometric and Tinnitus assessment: Basic audiometric tests, pitch match, loudness match, minimum masking level (MML)
- Tinnitus questionnaires: Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI) and Visual Analogue Scale (VAS)
- anthropometrics: body weight , height, Body Mass Index, waist and hip circumferences
- Nutrition and physical activity evaluation
- Adherence to the Mediterranean dietary pattern (MedDietScore)
- Psychological assessment
- Biochemical measurements: Complete blood count, lipid profile, glucose, electrolytes, liver enzymes, thyroid hormones
- Vitamin laboratory tests
- Oxidative stress assessment in serum samples: Total Antioxidant Capacity (TAC), Superoxide Dismutase (SOD) activity and Oxidized LDL are quantified.
Compliance and any side effects were checked with a weekly telephone contact with the patients. The consumption of tablets was checked with a diary completed by patients. At the end of the intervention, all baseline parameters were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidants | Active comparator | Dietary Supplement: AntioxidantsThis arm of patients received one multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm of patients received placebo for 3 months. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 25-75 years old
- Unilateral or bilateral chronic idiopathic persistent tinnitus of at least 6 months' duration
- Tinnitus Handicap Inventory score rated ≥ 4 at baseline
- With a normal audiogram or up to medium-grade neurosensory hearing loss.
- Tinnitus maskable (by noise masking) with noise at least 5 decibel
Key exclusion criteria (11 listed)
- Tinnitus following acute acoustic trauma, sudden deafness or traumatic head or neck injury
- Intermittent tinnitus
- Meniere's Disease, otosclerosis, acute or chronic otitis media
- Head and neck radiotherapy
- Active GI disease; active malignant diseases; autoimmune diseases; cardiovascular disease; renal or hepatic disorders; haemorrhagic diathesis
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 |
|---|---|---|
| Antioxidantsone multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months. | Dietary supplement | Antioxidants |
| Placeboone placebo tablet three times per day for 3 months. | Dietary supplement | Placebo |
Primary outcome
Tinnitus loudness (in decibel) assessed by loudness matching test
Time frame: Change in tinnitus loudness was assessed at 3 months from baseline in tinnitus patients
Mean Change from Baseline in Tinnitus loudness at three months assessed by Loudness matching audiometric test
Tinnitus Handicap Inventory Questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Time frame: Change in Tinnitus Handicap Inventory score was assessed at 3 months from baseline in tinnitus patients
Mean Change from Baseline in Tinnitus Handicap Inventory Questionnaire at three months
8 secondary outcomes
Tinnitus frequency (in Hz) assessed by pitch match test
Time frame: Change in Tinnitus frequency was assessed at 3 months from baseline in tinnitus patients
Tinnitus Functional Index questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Time frame: Change in Tinnitus Functional Index score was assessed at 3 months from baseline in tinnitus patients
serum Total Antioxidant Capacity (mM)
Time frame: Change in Serum Total Antioxidant Capacity was assessed at 3 months from baseline in tinnitus patients
Vitamins B12, E, C, B2, B1, B6 and folic acid in blood
Time frame: Change in vitamin levels were assessed at 3 months from baseline in tinnitus patients
Tinnitus Minimum Masking Level (in decibel)
Time frame: Change in Tinnitus Minimum Masking Level was assessed at 3 months from baseline in tinnitus patients
Visual Analogue Scale Score (ranging from 0 to 10) which assesses tinnitus annoyance
Time frame: Change in Visual Analogue Scale Score was assessed at 3 months from baseline in tinnitus patients
serum Superoxide Dismutase (U/ml)
Time frame: Change in serum Superoxide Dismutase was assessed at 3 months from baseline in tinnitus patients
serum Oxidized LDL (ng/ml)
Time frame: Change in serum Oxidized LDL was assessed at 3 months from baseline in tinnitus patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ioannis Xenelis, Professor study director
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antioxidants in people with Tinnitus, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 13 Nov 2019. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tinnitus loudness (in decibel) assessed by loudness matching test (time frame: Change in tinnitus loudness was assessed at 3 months from baseline in tinnitus patients). The study lists 2 primary outcomes in all. 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 13 Nov 2019.