Phase 2
Completed N=116
Zinc to Treat Tinnitus in the Elderly
Source: ClinicalTrials.gov NCT00683644 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months — 22.03; 24.9; 23.7; 25.4 units on a scale — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months |
22.03; 24.9; 23.7; 25.4 | >0.05 |
| SECONDARY Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment |
67.7; 66; 68.1; 67.6 | 0.89 |
| SECONDARY Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment |
59.67; 57.7; 61; 57.9 | 0.64 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00683644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.