Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
placebo pill
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of age or older
- •Tinnitus for 6 months or more
- •Normal copper levels
- •Be generally healthy
排除标准
- •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.
研究组 & 干预措施
1 - zinc placebo
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.
干预措施: Zinc (Drug)
1 - zinc placebo
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.
干预措施: Placebo oral capsule (Drug)
2 - placebo zinc
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.
干预措施: Zinc (Drug)
2 - placebo zinc
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.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months
时间窗: baseline - 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.
次要结局
- Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment(baseline and 4 months)
- Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment(baseline and 4 months)
研究者
Richard Tyler
Professor
University of Iowa