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Zinc to Treat Tinnitus in the Elderly

NCT ID: NCT00683644

Last Updated: 2017-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

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.

Conditions

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Tinnitus

Keywords

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tinnitus, zinc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
placebo pill

Study Groups

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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.

Group Type EXPERIMENTAL

Zinc

Intervention Type DRUG

Zinc taken once daily

Placebo oral capsule

Intervention Type DRUG

Placebo capsules taken once daily

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.

Group Type EXPERIMENTAL

Zinc

Intervention Type DRUG

Zinc taken once daily

Placebo oral capsule

Intervention Type DRUG

Placebo capsules taken once daily

Interventions

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Zinc

Zinc taken once daily

Intervention Type DRUG

Placebo oral capsule

Placebo capsules taken once daily

Intervention Type DRUG

Other Intervention Names

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zinc sulfate Placebo

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tinnitus Research Initiative

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Richard Tyler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard S. Tyler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Coelho C, Witt SA, Ji H, Hansen MR, Gantz B, Tyler R. Zinc to treat tinnitus in the elderly: a randomized placebo controlled crossover trial. Otol Neurotol. 2013 Aug;34(6):1146-54. doi: 10.1097/MAO.0b013e31827e609e.

Reference Type DERIVED
PMID: 23598691 (View on PubMed)

Other Identifiers

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200603807

Identifier Type: -

Identifier Source: org_study_id