NCT00808470

Brief Summary

Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue. Studies in animals have allowed us to identify mechanisms contributing to NIHL, including direct mechanical trauma, free radicals formed in association with metabolic stress, and reduced blood flow. A combination of antioxidant vitamins (beta-carotene, and vitamins C and E) and the mineral magnesium (which acts in part as a vasodilator but also as an antioxidant) is highly effective in preventing NIHL in animals. These studies evaluate efficacy of this intervention in humans. Hypothesis: Treatment with these micronutrients provides safe, effective attenuation of acute hearing changes induced by exposure to real-world sounds producing temporary (non-permanent) or permanent hearing changes induced by exposure to real-world sounds. Experiment 1: "Digital Audio Player" studies (University of Florida, Gainesville). Prevention of \*temporary\* elevations in hearing thresholds, induced by exposure to moderately loud music, will be measured. Subjects will be 70 young adults with equal numbers of male and female participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

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

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 19, 2017

Completed
Last Updated

May 19, 2017

Status Verified

April 1, 2017

Enrollment Period

5.2 years

First QC Date

December 11, 2008

Results QC Date

May 8, 2015

Last Update Submit

April 13, 2017

Conditions

Noise-Induced Hearing Loss

Keywords

NoiseHearing LossTinnitusAntioxidantVasodilatorBeta-CaroteneVitamin CVitamin EMagnesium

Outcome Measures

Primary Outcomes (1)

  • Average Threshold Shift at 4 kHz in Both Ears

    The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.

    15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Secondary Outcomes (2)

  • Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music

    15 min

  • Tinnitus

    immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Other Outcomes (4)

  • Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes

    15 min

  • Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz

    repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

  • Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures

    repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

  • +1 more other outcomes

Study Arms (2)

Nutrients

EXPERIMENTAL

Subjects in University of Florida music player study who are assigned to nutrient condition(beta-carotene, vitamins C and E, magnesium). Nutrient tablets are consumed for 4 days.

Drug: beta-carotene, vitamins C and E, magnesium

Placebo for nutrients

PLACEBO COMPARATOR

Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.

Other: Placebo

Interventions

beta-carotene, vitamins C and E, magnesiumDRUG

6 mint-flavored tablets per day, taken once daily total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene.

Also known as: Soundbites®
Nutrients
PlaceboOTHER

6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal.

Placebo for nutrients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subjects must have a normal audiologic assessment at baseline consisting of:
  • symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
  • no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
  • no significant air-bone gaps (i.e., greater than 10 dB); and
  • Type A tympanograms bilaterally, defined as a range of -140 to +40 daPa based on the 90% range for adults (Margolis \& Hunter 2000).
  • Additional criteria are as follows:
  • No history of ear disease, able to provide informed consent, agree to follow study procedures, normal health screening at study entry

You may not qualify if:

  • Pregnant or trying to become pregnant within study period (females)
  • subjects belonging to vulnerable populations
  • subjects with any history of chronic disease
  • hearing loss that exceeds limits specified above
  • inability or failure to provide informed consent
  • medical conditions that require treatment with drugs including anticoagulants
  • diuretics
  • digoxin
  • aspirin/salicylate
  • barbiturates
  • minocycline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

  • Le Prell CG, Fulbright A, Spankovich C, Griffiths SK, Lobarinas E, Campbell KC, Antonelli PJ, Green GE, Guire K, Miller JM. Dietary supplement comprised of beta-carotene, vitamin C, vitamin E, and magnesium: failure to prevent music-induced temporary threshold shift. Audiol Neurotol Extra. 2016 May-Aug;6(2):20-39. doi: 10.1159/000446600. Epub 2016 Jul 5.

    PMID: 27990155BACKGROUND

  • Le Prell CG, Johnson AC, Lindblad AC, Skjonsberg A, Ulfendahl M, Guire K, Green GE, Campbell KC, Miller JM. Increased vitamin plasma levels in Swedish military personnel treated with nutrients prior to automatic weapon training. Noise Health. 2011 Nov-Dec;13(55):432-43. doi: 10.4103/1463-1741.90317.

    PMID: 22122960RESULT

  • Spankovich C, Le Prell CG. Associations between dietary quality, noise, and hearing: data from the National Health and Nutrition Examination Survey, 1999-2002. Int J Audiol. 2014 Nov;53(11):796-809. doi: 10.3109/14992027.2014.921340. Epub 2014 Jun 30.

    PMID: 24975234DERIVED

  • Le Prell CG, Yang Q, Harris JG. Modification of digital music files for use in human temporary threshold shift studies. J Acoust Soc Am. 2011 Oct;130(4):EL142-6. doi: 10.1121/1.3630017.

    PMID: 21974483DERIVED

MeSH Terms

Conditions

Hearing Loss, Noise-InducedHearing LossTinnitus

Interventions

beta CaroteneMagnesium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Results Point of Contact

Title
Dr. Colleen Le Prell
Organization
University of Texas at Dallas
colleen.leprell@utdallas.edu
214-905-3018

Study Officials

  • Josef M Miller, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Colleen G Le Prell, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 15, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 19, 2017

Results First Posted

May 19, 2017

Record last verified: 2017-04

Locations

US(1)