NCT01273883

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 14, 2015

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

January 7, 2011

Results QC Date

January 7, 2015

Last Update Submit

April 9, 2015

Conditions

Tinnitus

Keywords

hearingmagnesium

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects

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

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

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

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

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

Study Arms (2)

Magnesium first, then placebo

EXPERIMENTAL

Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.

Dietary Supplement: MagnesiumOther: Placebo

Placebo first, then magnesium

PLACEBO COMPARATOR

Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.

Dietary Supplement: MagnesiumOther: Placebo

Interventions

MagnesiumDIETARY_SUPPLEMENT

Magnesium 532 mg a day

Magnesium first, then placeboPlacebo first, then magnesium
PlaceboOTHER

matching form/dosage

Magnesium first, then placeboPlacebo first, then magnesium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

  • 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.

    PMID: 22249877BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Results Point of Contact

Title
Dr. Michael J. Cevette
Organization
Mayo Clinic
mcevette@mayo.edu
480-301-7020

Study Officials

  • Michael Cevette, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Audiology, College of Medicine

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 11, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 30, 2015

Results First Posted

January 14, 2015

Record last verified: 2015-04

Locations

US(1)