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TinnitusPhase 3NCT01273883

A Trial of Magnesium Dependent Tinnitus

A Phase 3 study testing Magnesium in people with Tinnitus, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tinnitus
What is being tested?
Magnesium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
Jul 2011to Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase III Trial of Magnesium Dependent Tinnitus

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).

Read the 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.

Conditions
Tinnitus
Being tested
Magnesium, Placebo
Keywords
hearing, magnesium
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagnesiumDietary supplement

    Magnesium 532 mg a day

  • PlaceboOther

    matching form/dosage

Study groups in NCT01273883
Study groupRoleWhat they receive
Magnesium first, then placeboExperimentalMagnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
Receives: Dietary Supplement: Magnesium; Other: Placebo
Placebo first, then magnesiumPlacebo comparatorPlacebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
Receives: Dietary Supplement: Magnesium; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Distress Rating

    This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.

    Measured: Pre-treatment, Post-treatment, up to four weeks

Secondary outcomes (3)
  1. Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects

    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.

    Measured: Pre-treatment, Post-treatment, up to four weeks

  2. Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men

    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.

    Measured: Pre-treatment, Post-treatment, up to four weeks

  3. Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women

    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.

    Measured: Pre-treatment, Post-treatment, up to four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01273883
Sponsor's protocol ID
09-008292
Status last verified
Apr 2015
First submitted
7 Jan 2011
Last updated
30 Apr 2015
Data monitoring committee
No

Publications

  • Cevette MJ, Barrs DM, Patel A, Conroy KP, Sydlowski S, Noble BN, Nelson GA, Stepanek J. Phase 2 study examining magnesium-dependent tinnitus. Int Tinnitus J. 2011;16(2):168-73.

    PubMed 22249877

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magnesium in people with Tinnitus, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinnitus Distress Rating (time frame: Pre-treatment, Post-treatment, up to four weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01273883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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