Zinc Deficiency Clinical Trial
Official title:
Evaluation of the Effects of Zinc in the Management on Tinnitus Patients With Noise Induced Hearing Loss
Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were included. Each subject underwent an otoscopic examination, distortion product otoacoustic emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. After 2 months of treatment with zinc, all tests were repeated.
This study enrolled patients who visited our out-patient department with the primary
complaint of tinnitus. A full medical history assessment was performed, and each patient
underwent an otoscopic examination, a basic audiologic evaluation. We selected the patients
whose audiogram data met the inclusion criteria for NIHL: 1) bilateral typical NIHL
audiogram and type A tympanogram; 2) hearing threshold above 4 kilohertz (kHz) was greater
than 25 dB hearing level (HL); 3) audiogram showed the characteristic 4 kHz or 6 kHz notch
(average hearing threshold was 10 dB HL higher than the baseline); 4) up-turn phenomenon
appeared above 6 kHz or 8 kHz, and 5) symmetrical hearing loss threshold over bilateral ears
and the disparity was less than 10 dB HL. Patients with other otologic diseases were
excluded.
A full medical history assessment was performed, and each patient completed the NIHL
questionnaire (Supplementary S1), audiogram, tympanogram, speech discrimination test,
distortion product otoacoustic emissions (DPOAE) testing, pitch and loudness match of the
tinnitus, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. All tests were
repeated after 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental
zinc), two tablets twice per day (40 mg per day).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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