Zinc to Treat Tinnitus in the Elderly

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683644
• Other study ID #: 200603807
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2008
• Last updated: November 10, 2017
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: November 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Zinc
Zinc taken once daily
• Placebo oral capsule
Placebo capsules taken once daily

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Tinnitus Research Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline - 4 months
Secondary	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).	baseline and 4 months
Secondary	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)	baseline and 4 months