Zinc to Treat Tinnitus in the Elderly

University of Iowa

Status and phase: Completed; Phase 2

Conditions: Tinnitus

Treatments: Drug: Zinc; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT00683644

200603807

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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116 participants in 2 patient groups

1 - zinc placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo oral capsule

Drug: Zinc

2 - placebo zinc

Experimental group

Description:

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.

Treatment:

Drug: Placebo oral capsule

Drug: Zinc