Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tinnitus Research Initiative | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc | Drug | Zinc taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard S. Tyler, Ph.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23598691 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
recruited from audiology clinic in otolaryngology department
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Zinc First | Zinc sulfate (50 mg elemental zinc) taken once daily for 4 months ZINC 4 MONTHS WASHOUT 1 MONTH PLACEBO 4 MONTHS |
| FG001 | Group 2 Placebo First | Placebo capsules taken once a day for 4 months PLACEBO 4 MONTHS WASHOUT 1 MONTH ZINC 4 MONTHS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Zinc First | Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. Washout period of 30 days. Placebo capsules administered once a day for 4 months. |
| BG001 | Group 2 Placebo First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | For data analysis purposes subjects were recombined in 2 groups (Zinc and Placebo). Group ZINC: subjects who completed 4 months with Zinc 50 mg daily either from baseline to month 4, or after washout (from month 5 to 9). Group PLACEBO: subjects who completed 4 months with placebo either from baseline to month 4, or after washout (from month 5 to 9) | Posted | Mean | Standard Deviation | units on a scale | baseline - 4 months |
9 months
There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zinc | 54 participants received Zinc first and 45 participants received Zinc after 1 month washout. The total number of participants at risk to Zinc is 99. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| richard tyler | University of Iowa | 319 356 2471 | rich-tyler@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015032 | Zinc |
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
Not provided
Not provided
Not provided
Not provided
Not provided
placebo pill
| Placebo oral capsule | Drug | Placebo capsules taken once daily |
|
|
Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance) |
| baseline and 4 months |
| Adverse Event |
|
| Low copper, other health problems, |
|
Placebo capsules administered once a day for 4 months. Washout period of 30 days. Zinc sulfate 220 mg capsules, (corresponding to 50 mg of elemental zinc) administered once a day for 4 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tinnitus Handicap Questionaire | Mean | Standard Deviation | units on a scale |
|
| Tinnitus Annoyance Rating Scale | Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance) | Mean | Standard Deviation | units on a scale |
|
| Tinnitus Loudness Rating Scale | Tinnitus loudness rate on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception) | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Zinc | Participants that completed 4 months taking Zinc (50 mg) daily, either from baseline to month 4, or after washout period, from month 5 to 9). |
| OG001 | Placebo | Participants that completed 4 months taking placebo capsules daily, either from baseline to month 4 or after a washout period of 1 month (from month 5 to month 9). |
|
|
|
| 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). | Subjects that complete 4 months treatment | Posted | Mean | Standard Deviation | units on a scale | 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) | Subjects that complete 4 months treatment | Posted | Mean | Standard Deviation | units on a scale | baseline and 4 months |
|
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 1 |
| 99 |
| EG001 | Placebo | 55 participants received Placebo first and 46 participants received Placebo after 1 month washout. The total number of participants at risk to Placebo is 101. | 0 | 101 | 0 | 101 | 2 | 101 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Metallic taste | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D017967 | Zinc Compounds |
Threshold for significance is 0.05
| Other |
Threshold for significance is 0.05
| Other |