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A Trial of Magnesium Dependent Tinnitus

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ClinicalTrials.gov Identifier: NCT01273883
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : January 14, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Cevette, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Tinnitus
Interventions Dietary Supplement: Magnesium
Other: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Magnesium First, Then Placebo Placebo First, Then Magnesium
Hide Arm/Group Description Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo. Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
Period Title: First Intervention
Started 19 [1] 19 [1]
Completed 17 18
Not Completed 2 1
Reason Not Completed
Adverse Event             2             1
[1]
Received at least 1 dose of study drug.
Period Title: Washout Period of 2 Weeks
Started 17 18
Completed 17 18
Not Completed 0 0
Period Title: Second Intervention
Started 17 18
Completed 15 17
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             1
Lack of Efficacy             1             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive magnesium first and placebo first.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
61.45  (11.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
13
  34.2%
Male
25
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Tinnitus Distress Rating
Hide Description This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.
Time Frame Pre-treatment, Post-treatment, up to four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects completed the distress rating scale.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
Placebo administered daily in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 5.71  (1.94) 5.82  (1.94)
Post-treatment 5.36  (2.30) 5.46  (1.99)
2.Secondary Outcome
Title Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects
Hide Description 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.
Time Frame Pre-treatment, Post-treatment, up to four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects completed the THI questionnaire.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
Placebo administered daily in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 25.7  (22.2) 25.7  (19.4)
Post-treatment 24.1  (19.9) 23.2  (17.4)
3.Secondary Outcome
Title Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men
Hide Description 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.
Time Frame Pre-treatment, Post-treatment, up to four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all male subjects completed the THI questionnaire.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
Placebo administered daily in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 29.1  (24.7) 27.2  (22.0)
Post-treatment 27.8  (21.5) 25.3  (19.6)
4.Secondary Outcome
Title Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women
Hide Description 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.
Time Frame Pre-treatment, Post-treatment, up to four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all the female subjects completed the THI questionnaire.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Magnesium 532 mg administered daily in either first intervention period or second intervention period.
Placebo administered daily in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment 18.7  (14.7) 22.6  (12.7)
Post-treatment 16.4  (14.4) 18.4  (10.9)
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description Magnesium 532 mg administered daily in either first intervention period or second intervention period. Placebo administered daily in either first intervention period or second intervention period.
All-Cause Mortality
Magnesium Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Magnesium Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Magnesium Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/38 (18.42%)      3/38 (7.89%)    
Blood and lymphatic system disorders     
Elevated Blood Pressure   0/38 (0.00%)  0 1/38 (2.63%)  1
Intermittent Ankle Swelling   1/38 (2.63%)  1 0/38 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   3/38 (7.89%)  3 0/38 (0.00%)  0
Loose Stool   3/38 (7.89%)  3 1/38 (2.63%)  1
Lower Abdominal Discomfort   0/38 (0.00%)  0 1/38 (2.63%)  1
General disorders     
Headache   1/38 (2.63%)  1 0/38 (0.00%)  0
Emergency Room Visit   1/38 (2.63%)  1 1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders     
Pleurisy   0/38 (0.00%)  0 1/38 (2.63%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael J. Cevette
Organization: Mayo Clinic
Phone: 480-301-7020
EMail: mcevette@mayo.edu
Layout table for additonal information
Responsible Party: Michael Cevette, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01273883     History of Changes
Other Study ID Numbers: 09-008292
First Submitted: January 7, 2011
First Posted: January 11, 2011
Results First Submitted: January 7, 2015
Results First Posted: January 14, 2015
Last Update Posted: April 30, 2015