Zinc to Treat Tinnitus in the Elderly

NCT00683644 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 200603807
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

tinnitus, zinc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment

  baseline and 4 months

• Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment

  baseline and 4 months

Study Arms (2)

1 - zinc placebo

EXPERIMENTAL

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; Drug: Placebo oral capsule

2 - placebo zinc

EXPERIMENTAL

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; Drug: Placebo oral capsule

Interventions

Zinc DRUG

Zinc taken once daily

Also known as: zinc sulfate

1 - zinc placebo; 2 - placebo zinc

Placebo oral capsule DRUG

Placebo capsules taken once daily

Also known as: Placebo

1 - zinc placebo; 2 - placebo zinc

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Tinnitus for 6 months or more
• Normal copper levels
• Be generally healthy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead
• Tinnitus Research Initiative: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 23598691 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Zinc; Zinc Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Limitations and Caveats

For data analysis purposes subjects were divided "per intervention". Zinc: subjects who completed 4 mo with zinc from baseline to month 4, or after washout. Placebo: subjects who completed 4 mo with placebo from baseline to month 4, or after washout.

Results Point of Contact

• Title: richard tyler
• Organization: University of Iowa

rich-tyler@uiowa.edu

319 356 2471

Study Officials

• Richard S. Tyler, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: placebo pill
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)