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Zinc to Treat Tinnitus in the Elderly

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zinc
Placebo oral capsule
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, zinc

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1 - zinc placebo

2 - placebo zinc

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)

Full Information

First Posted
May 21, 2008
Last Updated
November 10, 2017
Sponsor
University of Iowa
Collaborators
Tinnitus Research Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT00683644
Brief Title
Zinc to Treat Tinnitus in the Elderly
Official Title
Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Tinnitus Research Initiative

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, zinc

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
placebo pill
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - zinc placebo
Arm Type
Experimental
Arm 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.
Arm Title
2 - placebo zinc
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Zinc
Other Intervention Name(s)
zinc sulfate
Intervention Description
Zinc taken once daily
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsules taken once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months
Description
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.
Time Frame
baseline - 4 months
Secondary Outcome Measure Information:
Title
Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment
Description
Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception).
Time Frame
baseline and 4 months
Title
Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment
Description
Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)
Time Frame
baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S. Tyler, Ph.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23598691
Citation
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.
Results Reference
derived

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Zinc to Treat Tinnitus in the Elderly

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