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A Study on the Effectiveness of Antioxidant Supplementation in Tinnitus

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ClinicalTrials.gov Identifier: NCT04105426
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Petridou, National and Kapodistrian University of Athens

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. 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.


Condition or disease Intervention/treatment Phase
Tinnitus Dietary Supplement: Antioxidants Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase-II Clinical Trial on the Effectiveness of Antioxidant Supplementation in Idiopathic Tinnitus Patients
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : May 25, 2019
Actual Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antioxidants
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.
Dietary Supplement: Antioxidants
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 Comparator: Placebo
This arm of patients received placebo for 3 months.
Dietary Supplement: Placebo
one placebo tablet three times per day for 3 months.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Mean Change from Baseline in Tinnitus frequency at three months

  2. 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 ]
    Mean Change from Baseline in Tinnitus Functional Index score at three months

  3. serum Total Antioxidant Capacity (mM) [ Time Frame: Change in Serum Total Antioxidant Capacity was assessed at 3 months from baseline in tinnitus patients ]
    Mean Change from Baseline in Serum Total Antioxidant Capacity at three months

  4. 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 ]
    Mean Change from Baseline in vitamin levels at three months

  5. Tinnitus Minimum Masking Level (in decibel) [ Time Frame: Change in Tinnitus Minimum Masking Level was assessed at 3 months from baseline in tinnitus patients ]
    Mean Change from Baseline in Tinnitus Minimum Masking Level at three months

  6. 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 ]
    Mean Change from Baseline in Visual Analogue Scale Score at three months

  7. serum Superoxide Dismutase (U/ml) [ Time Frame: Change in serum Superoxide Dismutase was assessed at 3 months from baseline in tinnitus patients ]
    Mean Change from Baseline in serum Superoxide Dismutase at three months

  8. serum Oxidized LDL (ng/ml) [ Time Frame: Change in serum Oxidized LDL was assessed at 3 months from baseline in tinnitus patients ]
    Mean Change from Baseline in serum Oxidized LDL at three months



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105426


Locations
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Greece
General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology
Athens, Greece
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Study Director: Ioannis Xenelis, Professor General Hospital of Athens "Hippocratio", Department of Otorhinolaryngology

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Responsible Party: Anna Petridou, Dietitian-Nutritionist, M.Med.Sci, PhD candidate, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04105426     History of Changes
Other Study ID Numbers: 4354
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs