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Efficacy of zinc supplement on tinnitus: A double-blind randomized controlled trial

Efficacy of zinc supplement on tinnitus: A double-blind randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241027001
Enrollment
92
Registered
2024-10-27
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective nonpulsatile tinnitus in patients aged 20 to 80 years, with onset ranging from 2 months to 2 years tinnitus zinc zinc sulphate

Interventions

Receive oral zinc sulphate, 25 mg, one tablet taken twice daily for 8 weeks,Receive oral placebo, one tablet taken twice daily for 8 weeks.
Experimental Drug,Placebo Comparator Drug
Zinc,Control

Sponsors

Pattheera Suwannik, M.D.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients have subjective nonpulsatile tinnitus 2. Duration of tinnitus onset is between 2 months and 2 years 3. Willingness to participate in the study. 4. Ability to comply with follow-up requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with diagnosed outer or middle ear conditions, such as tumors, outer ear infections, middle ear infections, or otitis media with effusion. 2. Patients with conductive hearing loss. 3. Patients with retrocochlear lesions (lesions beyond the cochlea). 4. Patients with a history of ear surgery, mastoid surgery, or brain surgery. 5. Patients with iron deficiency anemia or those currently receiving iron supplements. 6. Patients with specific underlying medical conditions, including: Chronic kidney disease with an Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2, Cirrhosis or hepatitis with abnormal liver enzymes, HIV infection or those receiving antiretroviral medication, Autoimmune diseases, Dementia, Psychiatric disorders 7. Pregnant or breastfeeding individuals. 8. History of adverse reactions to zinc supplements.

Design outcomes

Primary

MeasureTime frame
Tinnitus Handicap Inventory Before treatment, at 4 weeks, and 8 weeks after starting treatment Patient reported outcome using a questionnaire interview of Tinnitus Handicap Inventory scores

Secondary

MeasureTime frame
Hearing Level Before treatment, at 4 weeks, and 8 weeks after starting treatment Hearing threshold difference: comparing air conduction audiometry at frequencies of 250 Hz, 500 Hz, 1 kHz, 2 kHz, 4 kHz, 8 kHz, 9 kHz, 10 kHz, 11.2 kHz, 12.5 kHz, 14 kHz, 16 kHz, 18 kHz, and 20 kHz,Tinnitus loundness Before treatment, at 4 weeks, and 8 weeks after starting treatment Tinnitus matching test, in which participants match the loudness of their tinnitus to a reference tone they can hear,DPOAE Before treatment II. Distortion-product Otoacoustic Emissions,Zinc level Before, and 8 weeks after starting treatment Serum zinc level,Anemia Before, and 8 weeks after starting treatment Hemoglobin level

Countries

Thailand

Contacts

Public ContactPattheera Suwannik

Otolaryngology Head and Neck Surgery Department, Phramongkutklao Hospital

pattheera.suw@gmail.com027633073

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026