A Trial of Magnesium Dependent Tinnitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Cevette, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01273883
First received: January 7, 2011
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 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 (Cevette et al, 2003). Permanent and temporary changes in auditory function have been linked to nutritional deficiencies of magnesium. Magnesium deficiency has resulted in increased susceptibility to noise-induced hearing loss (Ising et al, 1982; Joachims et al, 1983; Joachims et al, 1987; Scheibe et al, 2000), ototoxicity (Vormann and Gunther, 1993), and hyperexcitability (Kruse et al, 1932; Cevette et al, 1989; Bac et al, 1994) of the auditory system.

The recommended daily allowance (RDA) for magnesium in adults is 4.5 mg/kg (Saris et al, 2000); however, all age groups of Americans fall short of the RDA for magnesium by 100 mg daily (Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1997). This lack of appropriate magnesium intake may have negative consequences. For example, the putative magnesium mechanism within the auditory system involves a metabolic cellular cascade of events. Specifically, magnesium 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 magnesium supplementation may lessen the severity of tinnitus in patients. Magnesium improved hearing recovery and lessened tinnitus in patients with idiopathic sudden hearing loss (Gordin et al, 2002). More recently, Nageris et al (2004) showed in a well-controlled study that magnesium 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 magnesium in noise-induced hearing loss has been previously reported (Ising et al, 1982; Scheibe et al, 2000).

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


Condition Intervention Phase
Tinnitus
Dietary Supplement: Magnesium
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase III Trial of Magnesium Dependent Tinnitus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Tinnitus Distress Rating [ Time Frame: 4 & 10 weeks ] [ Designated as safety issue: No ]
    The purpose of this study is to examine any change in the perception of tinnitus in patients supplemented with magnesium (535 mg daily).


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium Dietary Supplement: Magnesium
Magnesium 532 mg a day
Placebo Comparator: Placebo (Sugar pill) Other: Placebo
matching form/dosage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Normal Kidney function (last checked within 6 months)
  • 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
  • Current treatment with Lithium
  • Tinnitus rating with 0, 1, or 2 on the 0-10 Tinnitus scale
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273883

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Cevette, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Cevette, Associate Professor of Audiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01273883     History of Changes
Other Study ID Numbers: 09-008292
Study First Received: January 7, 2011
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014