Trial Outcomes & Findings for Zinc to Treat Tinnitus in the Elderly (NCT NCT00683644)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

baseline - 4 months

Results posted on

2017-12-13

Participant Flow

recruited from audiology clinic in otolaryngology department

Participant milestones

Participant milestones
Measure	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	Group 2 Placebo First Placebo capsules taken once a day for 4 months PLACEBO 4 MONTHS WASHOUT 1 MONTH ZINC 4 MONTHS
Overall Study STARTED	58	58
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Group 2 Placebo First Placebo capsules taken once a day for 4 months PLACEBO 4 MONTHS WASHOUT 1 MONTH ZINC 4 MONTHS
Overall Study Withdrawal by Subject	4	2
Overall Study Lost to Follow-up	1	4
Overall Study Adverse Event	1	2
Overall Study Low copper, other health problems,	7	6

Baseline Characteristics

Zinc to Treat Tinnitus in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Zinc First n=58 Participants 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.	Group 2 Placebo First n=58 Participants 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.	Total n=116 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 5.5 • n=5 Participants	67.8 years STANDARD_DEVIATION 5.8 • n=7 Participants	67.8 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	58 participants n=7 Participants	109 participants n=5 Participants
Tinnitus Handicap Questionaire	28.4 units on a scale STANDARD_DEVIATION 20.3 • n=5 Participants	27.4 units on a scale STANDARD_DEVIATION 19.2 • n=7 Participants	27.9 units on a scale STANDARD_DEVIATION 19.8 • n=5 Participants
Tinnitus Annoyance Rating Scale	60 units on a scale STANDARD_DEVIATION 22.7 • n=5 Participants	65.8 units on a scale STANDARD_DEVIATION 23 • n=7 Participants	63 units on a scale STANDARD_DEVIATION 23.1 • n=5 Participants
Tinnitus Loudness Rating Scale	66.7 units on a scale STANDARD_DEVIATION 16.2 • n=5 Participants	67.5 units on a scale STANDARD_DEVIATION 15.1 • n=7 Participants	67.3 units on a scale STANDARD_DEVIATION 15.6 • n=5 Participants

PRIMARY outcome

Timeframe: baseline - 4 months

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Zinc n=93 Participants 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).	Placebo n=94 Participants 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).
Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months THQ scores at Baseline	22.03 units on a scale Standard Deviation 22	24.9 units on a scale Standard Deviation 20.7
Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months THQ scores at 4 months	23.7 units on a scale Standard Deviation 18.7	25.4 units on a scale Standard Deviation 21.3

SECONDARY outcome

Timeframe: baseline and 4 months

Population: Subjects that complete 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).

Outcome measures

Outcome measures
Measure	Zinc n=93 Participants 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).	Placebo n=93 Participants 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).
Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment Baseline tinnitus loudness rating scores (SD)	67.7 units on a scale Standard Deviation 18.7	66 units on a scale Standard Deviation 18.4
Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment 4 months tinnitus loudness rating scores (SD)	68.1 units on a scale Standard Deviation 21.4	67.6 units on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: baseline and 4 months

Population: Subjects that complete 4 months treatment

Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)

Outcome measures

Outcome measures
Measure	Zinc n=93 Participants 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).	Placebo n=93 Participants 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).
Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment Baseline tinnitus annoyance rating scores	59.67 units on a scale Standard Deviation 25.40	57.7 units on a scale Standard Deviation 30.85
Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment 4 months tinnitus annoyance rating scores	61 units on a scale Standard Deviation 30.5	57.9 units on a scale Standard Deviation 26.7

Adverse Events

Zinc

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zinc n=99 participants at risk 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.	Placebo n=101 participants at risk 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.
Gastrointestinal disorders Indigestion	1.0% 1/99 • Number of events 1 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.	0.00% 0/101 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.
Gastrointestinal disorders Constipation	0.00% 0/99 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.	0.99% 1/101 • Number of events 1 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.
Gastrointestinal disorders Metallic taste	0.00% 0/99 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.	0.99% 1/101 • Number of events 1 • 9 months There were 99 participants at risk while receiving Zinc and 101 participants at risk when receiving Placebo.

Additional Information

richard tyler

University of Iowa

Phone: 319 356 2471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place