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Zinc to Treat Tinnitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tinnitus Research Initiative
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00683644
First received: May 21, 2008
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

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
Experimental: 1
Zinc first, then placebo
 Dietary Supplement: Zinc sulfate
Zinc sulfate taken once daily
Experimental: 2
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: Richard S. Tyler, Ph.D., University of Iowa
ClinicalTrials.gov Identifier: NCT00683644     History of Changes
Other Study ID Numbers: TRI Grant RT 06 10
Study First Received: May 21, 2008
Last Updated: February 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Zinc
 Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013