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A Trial of Magnesium Dependent Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
The purpose of this study was to examine any potential benefit in lessening the severity of tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with magnesium (532 mg daily).

Condition or disease Intervention/treatment Phase
Tinnitus Dietary Supplement: Magnesium Other: Placebo Phase 3

Detailed Description:

Descriptions of tinnitus date back to the time of ancient Egypt, yet science has failed to unravel the mysterious underlying mechanisms that produce these subjective auditory perceptions of sound. These perceptions may be manifestations of damage resulting from noise exposure, ototoxicity, or other abnormal conditions of the auditory system. However, many individuals have idiopathic tinnitus for which no specific cause can be determined. Although often presenting in conjunction with hearing loss, the magnitude of hearing loss does not necessarily correspond with the severity of tinnitus. In addition, some individuals reporting tinnitus experience concomitant hyperacusis. This relationship suggests these processes may be linked by underlying imbalances at the level of the hair cell. The possible influence of magnesium (Mg) and its antagonist, calcium, has been discussed in the literature as a contributing factor in the mitigation of noise-induced hearing loss, ototoxicity, and the hyperexcitability of the auditory system. Permanent and temporary changes in auditory function have been linked to nutritional deficiencies of magnesium. Mg deficiency has resulted in increased susceptibility to noise-induced hearing loss, ototoxicity, and hyperexcitability of the auditory system.

The recommended daily allowance (RDA) for Mg in adults is 4.5 mg/kg; however, all age groups of Americans fall short of the RDA for Mg by 100 mg daily. This lack of appropriate magnesium intake may have negative consequences. For example, the putative Mg mechanism within the auditory system involves a metabolic cellular cascade of events. Specifically, Mg deficiency leads to increased permeability of the calcium channel in the hair cells with a consequent over-influx of calcium, an increased release of glutamate via exocytosis, and overstimulation of N-methyl-D-aspartate receptors on the auditory nerve fibers. Recent studies of both noise-induced hearing loss and idiopathic sensorineural hearing loss have suggested that Mg supplementation may lessen the severity of tinnitus in patients. Mg improved hearing recovery and lessened tinnitus in patients with idiopathic sudden hearing loss. More recently, a well-controlled study that Mg was a relatively safe and convenient adjunct to corticosteroid treatment for enhancing the improvements of hearing in acute-onset sensorineural hearing loss at a dose of 4 g. The protective effect of Mg in noise-induced hearing loss has been previously reported.

Despite these encouraging findings, no controlled study has examined the effect of Mg supplementation for subjects with moderate to severe tinnitus.

In this study subjects made 4 visits to the clinic over about 2 months. At the first visit, subjects had a hearing test. Prior to beginning each round of supplements, subjects were asked to rate the severity of their tinnitus on a 1-10 scale, and to complete the Tinnitus Handicap Inventory (THI) questionnaire. Subjects were then randomized to 1 of 2 groups. One group began with 532 mg of Mg for 25 days, the other group began with a placebo supplement for 25 days.

At visit 2, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire as well as the Treatment Period Survey. Subjects did not take any supplement for 2 weeks, then returned for visit 3.

At Visit 3, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire they then took the opposite supplement (placebo or Mg) for 25 days.

At Visit 4, the subjects had a hearing test, rated their tinnitus, and completed the THI questionnaire as well as the Treatment Period Survey.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: A Phase III Trial of Magnesium Dependent Tinnitus
Study Start Date : July 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: Magnesium first, then placebo
Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
Dietary Supplement: Magnesium
Magnesium 532 mg a day

Other: Placebo
matching form/dosage

Placebo Comparator: Placebo first, then magnesium
Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
Dietary Supplement: Magnesium
Magnesium 532 mg a day

Other: Placebo
matching form/dosage




Primary Outcome Measures :
  1. Tinnitus Distress Rating [ Time Frame: Pre-treatment, Post-treatment, up to four weeks ]
    This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.


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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Normal Kidney function (last checked within 6 months). Serum creatinine levels 1.5 mg/dL or below for females, 2.0 mg/dL for males.
  • An audiogram within the past 6 months
  • Mayo Clinic patients who live in Phoenix area

Exclusion criteria:

  • Any participant with decreased kidney function within past 6 months, over 1.5 mg/dL for females and over 2.0 mg/dL for males.
  • Current treatment with Lithium
  • Tinnitus rating with 0, 1, or 2 on the 0-10 Tinnitus scale

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273883


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael Cevette, PhD Mayo Clinic
Publications:
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Responsible Party: Michael Cevette, Associate Professor of Audiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01273883    
Other Study ID Numbers: 09-008292
First Posted: January 11, 2011    Key Record Dates
Results First Posted: January 14, 2015
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by Michael Cevette, Mayo Clinic:
hearing
magnesium
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases