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Completed

NCT Number: NCT00683644

Zinc to Treat Tinnitus in the Elderly

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc

Drug

Zinc taken once daily

Other names: zinc sulfate

Placebo oral capsule

Drug

Placebo capsules taken once daily

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Tinnitus Research Initiative

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 23, 2008
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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