A Trial of Magnesium Dependent Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Cevette, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01273883
First received: January 7, 2011
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: January 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Tinnitus
Interventions: Dietary Supplement: Magnesium
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow for 3 periods

Period 1:   First Intervention
    Magnesium First, Then Placebo     Placebo First, Then Magnesium  
STARTED     19 [1]   19 [1]
COMPLETED     17     18  
NOT COMPLETED     2     1  
Adverse Event                 2                 1  
[1] Received at least 1 dose of study drug.

Period 2:   Washout Period of 2 Weeks
    Magnesium First, Then Placebo     Placebo First, Then Magnesium  
STARTED     17     18  
COMPLETED     17     18  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Magnesium First, Then Placebo     Placebo First, Then Magnesium  
STARTED     17     18  
COMPLETED     15     17  
NOT COMPLETED     2     1  
Lost to Follow-up                 1                 1  
Lack of Efficacy                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive magnesium first and placebo first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean (Standard Deviation)
  61.45  (11.58)  
Gender  
[units: participants]
 
Female     13  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures
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1.  Primary:   Tinnitus Distress Rating   [ Time Frame: Pre-treatment, Post-treatment, up to four weeks ]

2.  Secondary:   Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects   [ Time Frame: Pre-treatment, Post-treatment, up to four weeks ]

3.  Secondary:   Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men   [ Time Frame: Pre-treatment, Post-treatment, up to four weeks ]

4.  Secondary:   Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women   [ Time Frame: Pre-treatment, Post-treatment, up to four weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael J. Cevette
Organization: Mayo Clinic
phone: 480-301-7020
e-mail: mcevette@mayo.edu


Publications:

Responsible Party: Michael Cevette, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01273883     History of Changes
Other Study ID Numbers: 09-008292
Study First Received: January 7, 2011
Results First Received: January 7, 2015
Last Updated: April 9, 2015
Health Authority: United States: Institutional Review Board