Zinc to Treat Tinnitus in the Elderly
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ClinicalTrials.gov Identifier: NCT00683644 |
Recruitment Status :
Completed
First Posted : May 23, 2008
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus | Drug: Zinc Drug: Placebo oral capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | placebo pill |
Primary Purpose: | Treatment |
Official Title: | Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial. |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 - zinc placebo
Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months. Washout 1 month. Placebo oral capsule taken once a day for 4 months.
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Drug: Zinc
Zinc taken once daily
Other Name: zinc sulfate Drug: Placebo oral capsule Placebo capsules taken once daily
Other Name: Placebo |
Experimental: 2 - placebo zinc
Placebo oral capsule taken once a day for 4 months. Washout 1 month. Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months.
|
Drug: Zinc
Zinc taken once daily
Other Name: zinc sulfate Drug: Placebo oral capsule Placebo capsules taken once daily
Other Name: Placebo |
- Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months [ Time Frame: baseline - 4 months ]Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures.
- Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment [ Time Frame: baseline and 4 months ]Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception).
- Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment [ Time Frame: baseline and 4 months ]Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 60 years of age or older
- Tinnitus for 6 months or more
- Normal copper levels
- Be generally healthy
Exclusion Criteria:
- Have a treatable otological disorder
- Involved in litigation
- Have or are suspected of having a serious psychiatric problem
- Involved in other treatments for tinnitus
- Are taking drugs which might interact with zinc and result in tinnitus
- Have copper deficiency
- Have Zinc levels above normal
- Are cognitively impaired.

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): NCT00683644
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Richard S. Tyler, Ph.D. | University of Iowa |
Responsible Party: | Richard Tyler, Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT00683644 |
Other Study ID Numbers: |
200603807 |
First Posted: | May 23, 2008 Key Record Dates |
Results First Posted: | December 13, 2017 |
Last Update Posted: | December 13, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
tinnitus, zinc |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Zinc |
Zinc Sulfate Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Astringents Dermatologic Agents |