Trial Outcomes & Findings for A Trial of Magnesium Dependent Tinnitus (NCT NCT01273883)
NCT ID: NCT01273883
Last Updated: 2015-04-30
Results Overview
This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
Pre-treatment, Post-treatment, up to four weeks
Results posted on
2015-04-30
Participant Flow
Participant milestones
| Measure |
Magnesium First, Then Placebo
Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
|
Placebo First, Then Magnesium
Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
|
|---|---|---|
|
First Intervention
STARTED
|
19
|
19
|
|
First Intervention
COMPLETED
|
17
|
18
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Washout Period of 2 Weeks
STARTED
|
17
|
18
|
|
Washout Period of 2 Weeks
COMPLETED
|
17
|
18
|
|
Washout Period of 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
17
|
18
|
|
Second Intervention
COMPLETED
|
15
|
17
|
|
Second Intervention
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Magnesium First, Then Placebo
Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
|
Placebo First, Then Magnesium
Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
|
|---|---|---|
|
First Intervention
Adverse Event
|
2
|
1
|
|
Second Intervention
Lost to Follow-up
|
1
|
1
|
|
Second Intervention
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
A Trial of Magnesium Dependent Tinnitus
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=38 Participants
Includes groups randomized to receive magnesium first and placebo first.
|
|---|---|
|
Age, Continuous
|
61.45 years
STANDARD_DEVIATION 11.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, Post-treatment, up to four weeksPopulation: Not all subjects completed the distress rating scale.
This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.
Outcome measures
| Measure |
Magnesium
n=28 Participants
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
|
Placebo
n=28 Participants
Placebo administered daily in either first intervention period or second intervention period.
|
|---|---|---|
|
Tinnitus Distress Rating
Pre-treatment
|
5.71 units on a scale
Standard Deviation 1.94
|
5.82 units on a scale
Standard Deviation 1.94
|
|
Tinnitus Distress Rating
Post-treatment
|
5.36 units on a scale
Standard Deviation 2.30
|
5.46 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Pre-treatment, Post-treatment, up to four weeksPopulation: Not all subjects completed the THI questionnaire.
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Outcome measures
| Measure |
Magnesium
n=28 Participants
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
|
Placebo
n=28 Participants
Placebo administered daily in either first intervention period or second intervention period.
|
|---|---|---|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects
Pre-treatment
|
25.7 units on a scale
Standard Deviation 22.2
|
25.7 units on a scale
Standard Deviation 19.4
|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects
Post-treatment
|
24.1 units on a scale
Standard Deviation 19.9
|
23.2 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Pre-treatment, Post-treatment, up to four weeksPopulation: Not all male subjects completed the THI questionnaire.
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Outcome measures
| Measure |
Magnesium
n=19 Participants
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
|
Placebo
n=19 Participants
Placebo administered daily in either first intervention period or second intervention period.
|
|---|---|---|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men
Pre-treatment
|
29.1 units on a scale
Standard Deviation 24.7
|
27.2 units on a scale
Standard Deviation 22.0
|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men
Post-treatment
|
27.8 units on a scale
Standard Deviation 21.5
|
25.3 units on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Pre-treatment, Post-treatment, up to four weeksPopulation: Not all the female subjects completed the THI questionnaire.
The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.
Outcome measures
| Measure |
Magnesium
n=9 Participants
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
|
Placebo
n=9 Participants
Placebo administered daily in either first intervention period or second intervention period.
|
|---|---|---|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women
Pre-treatment
|
18.7 units on a scale
Standard Deviation 14.7
|
22.6 units on a scale
Standard Deviation 12.7
|
|
Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women
Post-treatment
|
16.4 units on a scale
Standard Deviation 14.4
|
18.4 units on a scale
Standard Deviation 10.9
|
Adverse Events
Magnesium
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Magnesium
n=38 participants at risk
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
|
Placebo
n=38 participants at risk
Placebo administered daily in either first intervention period or second intervention period.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
3/38 • Number of events 3 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
General disorders
Headache
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
Blood and lymphatic system disorders
Elevated Blood Pressure
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
Gastrointestinal disorders
Loose Stool
|
7.9%
3/38 • Number of events 3 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
Gastrointestinal disorders
Lower Abdominal Discomfort
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
General disorders
Emergency Room Visit
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
|
Blood and lymphatic system disorders
Intermittent Ankle Swelling
|
2.6%
1/38 • Number of events 1 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
0.00%
0/38 • Tinnitus patients who presented to the Ear, Nose, and Throat (ENT) department of the Mayo Clinic in Arizona from 2009 to 2012 were screened and asked to participate.
Adverse events during the study will be reported to the study team by the research coordinator who will query the subjects as part of each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place