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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
Sponsor:
Collaborator:
Tinnitus Research Initiative
Information provided by (Responsible Party):
Richard Tyler, University of Iowa

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Zinc Drug: Placebo oral capsule Phase 2

Detailed 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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Tinnitus Research Initiative
Investigators
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Principal Investigator: Richard S. Tyler, Ph.D. University of Iowa
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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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
Keywords provided by Richard Tyler, University of Iowa:
tinnitus, zinc
Additional relevant MeSH terms:
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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