Zinc to Treat Tinnitus

This study is currently recruiting participants.

Verified by University of Iowa, February 2009

First Received: May 21, 2008 Last Updated: February 13, 2009 History of Changes

Sponsors and Collaborators:	University of Iowa Tinnitus Research Initiative
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00683644

Purpose

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	Intervention	Phase
Tinnitus	Dietary Supplement: Zinc sulfate	Phase II

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Zinc sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Zinc to Treat Tinnitus in the Elderly

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Tinnitus loudness and annoyance [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tinnitus handicap [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Zinc first, then placebo	Dietary Supplement: Zinc sulfate Zinc sulfate taken once daily
2: Experimental Placebo first, then zinc	Dietary Supplement: Zinc sulfate Zinc sulfate taken once daily

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683644

Contacts

Contact: Anne Gehringer

319-353-8760

Locations

United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Richard S. Tyler, Ph.D.

Sponsors and Collaborators

University of Iowa

Tinnitus Research Initiative

Investigators

Principal Investigator:

Richard S. Tyler, Ph.D.

University of Iowa

More Information

No publications provided

Responsible Party:	University of Iowa ( Richard S. Tyler, Ph.D. )
Study ID Numbers:	TRI Grant RT 06 10
Study First Received:	May 21, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00683644 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases
Zinc Sulfate
Zinc

Neurologic Manifestations
Trace Elements
Micronutrients
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Sensation Disorders
Otorhinolaryngologic Diseases
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Trace Elements
Tinnitus
Ear Diseases
Pharmacologic Actions

Signs and Symptoms
Hearing Disorders
Zinc Sulfate
Therapeutic Uses
Zinc
Astringents
Neurologic Manifestations
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009