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

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

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

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
United States, Arizona | |
Mayo Clinic in Arizona | |
Scottsdale, Arizona, United States, 85259 |
Principal Investigator: | Michael Cevette, PhD | Mayo Clinic |
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 |
hearing magnesium |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |