Zinc to Treat Tinnitus in the Elderly

Study Overview
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Brief Summary
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There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.

Detailed Description
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There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group. 116 patients were tested. Tinnitus loudness and the Tinnitus Handicap Questionnaire are the outcome measures.

Official Title
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Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial.

Conditions
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Tinnitus

Intervention / Treatment
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* Drug: Zinc
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - zinc placebo<br>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. | Drug: Zinc<br>* Zinc taken once daily<br>* Other names: zinc sulfate;Drug: Placebo oral capsule<br>* Placebo capsules taken once daily<br>* Other names: Placebo;|
| Experimental: 2 - placebo zinc<br>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<br>* Zinc taken once daily<br>* Other names: zinc sulfate;Drug: Placebo oral capsule<br>* Placebo capsules taken once daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 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. | baseline - 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment | Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception). | baseline and 4 months | 
| Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment | Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance) | baseline and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, zinc