A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Antioxidants
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antioxidants
Placebo
Arm Description
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.
This arm of patients received placebo for 3 months.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Tinnitus frequency (in Hz) assessed by pitch match test
Mean Change from Baseline in Tinnitus frequency at three months
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
serum Total Antioxidant Capacity (mM)
Mean Change from Baseline in Serum Total Antioxidant Capacity at three months
Vitamins B12, E, C, B2, B1, B6 and folic acid in blood
Mean Change from Baseline in vitamin levels at three months
Tinnitus Minimum Masking Level (in decibel)
Mean Change from Baseline in Tinnitus Minimum Masking Level at three months
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
serum Superoxide Dismutase (U/ml)
Mean Change from Baseline in serum Superoxide Dismutase at three months
serum Oxidized LDL (ng/ml)
Mean Change from Baseline in serum Oxidized LDL at three months
Full Information
NCT ID
NCT04105426
First Posted
September 23, 2019
Last Updated
November 11, 2019
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04105426
Brief Title
A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
Official Title
A Phase-II Clinical Trial on the Effectiveness of Antioxidant Supplementation in Idiopathic Tinnitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidants
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm of patients received placebo for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidants
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
one placebo tablet three times per day for 3 months.
Primary Outcome Measure Information:
Title
Tinnitus loudness (in decibel) assessed by loudness matching test
Description
Mean Change from Baseline in Tinnitus loudness at three months assessed by Loudness matching audiometric test
Time Frame
Change in tinnitus loudness was assessed at 3 months from baseline in tinnitus patients
Title
Tinnitus Handicap Inventory Questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Description
Mean Change from Baseline in Tinnitus Handicap Inventory Questionnaire at three months
Time Frame
Change in Tinnitus Handicap Inventory score was assessed at 3 months from baseline in tinnitus patients
Secondary Outcome Measure Information:
Title
Tinnitus frequency (in Hz) assessed by pitch match test
Description
Mean Change from Baseline in Tinnitus frequency at three months
Time Frame
Change in Tinnitus frequency was assessed at 3 months from baseline in tinnitus patients
Title
Tinnitus Functional Index questionnaire score (ranging from 0 to 100) which assesses the impact of tinnitus on daily life
Description
Mean Change from Baseline in Tinnitus Functional Index score at three months
Time Frame
Change in Tinnitus Functional Index score was assessed at 3 months from baseline in tinnitus patients
Title
serum Total Antioxidant Capacity (mM)
Description
Mean Change from Baseline in Serum Total Antioxidant Capacity at three months
Time Frame
Change in Serum Total Antioxidant Capacity was assessed at 3 months from baseline in tinnitus patients
Title
Vitamins B12, E, C, B2, B1, B6 and folic acid in blood
Description
Mean Change from Baseline in vitamin levels at three months
Time Frame
Change in vitamin levels were assessed at 3 months from baseline in tinnitus patients
Title
Tinnitus Minimum Masking Level (in decibel)
Description
Mean Change from Baseline in Tinnitus Minimum Masking Level at three months
Time Frame
Change in Tinnitus Minimum Masking Level was assessed at 3 months from baseline in tinnitus patients
Title
Visual Analogue Scale Score (ranging from 0 to 10) which assesses tinnitus annoyance
Description
Mean Change from Baseline in Visual Analogue Scale Score at three months
Time Frame
Change in Visual Analogue Scale Score was assessed at 3 months from baseline in tinnitus patients
Title
serum Superoxide Dismutase (U/ml)
Description
Mean Change from Baseline in serum Superoxide Dismutase at three months
Time Frame
Change in serum Superoxide Dismutase was assessed at 3 months from baseline in tinnitus patients
Title
serum Oxidized LDL (ng/ml)
Description
Mean Change from Baseline in serum Oxidized LDL at three months
Time Frame
Change in serum Oxidized LDL was assessed at 3 months from baseline in tinnitus patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Xenelis, Professor
Organizational Affiliation
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
City
Athens
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus
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