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Micronutrients to Prevent Noise-induced Hearing Loss

This study has been completed.
Sponsor:
Collaborators:
University of Florida
Karolinska Institutet
Southern Illinois University
Hearing Health Science Inc (clinical supply funding: mint tablets)
OtoMedicine Inc (clinical supply funding: capsules)
Information provided by (Responsible Party):
Josef M Miller, University of Michigan
ClinicalTrials.gov Identifier:
NCT00808470
First received: December 11, 2008
Last updated: January 23, 2014
Last verified: January 2014

December 11, 2008
January 23, 2014
October 2008
December 2013   (final data collection date for primary outcome measure)
Average threshold shift at 4 kHz in both ears [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
Maximum threshold shift at 3, 4, or 6 kHz in either ear [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00808470 on ClinicalTrials.gov Archive Site
  • Threshold shift at individual frequencies, including 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12.5, 14 and 16 kHz [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
  • Distortion Product Otoacoustic Emission (DPOAE) amplitude [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
  • Tinnitus [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
  • Threshold shift at individual frequencies, including 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12.5, 14 and 16 kHz [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ] [ Designated as safety issue: No ]
  • Distortion Product Otoacoustic Emission (DPOAE) amplitude [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ] [ Designated as safety issue: No ]
  • Tinnitus [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes. Tests at 1 year and 2 years to measure permanent changes in Spanish studies. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Micronutrients to Prevent Noise-induced Hearing Loss
Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player

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.

Experiment 2: "Urban warfare" military studies (Karolinska Institutet, Sweden). Prevention of *temporary* elevations in hearing thresholds, induced by automatic gunfire sound inside a concrete bunker, will be measured. Subjects will be 31 adult male or female officers in the Swedish army required to participate in urban combat training regardless of study participation. All subjects are required to wear standard hearing protection during combat exercises.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Noise-Induced Hearing Loss
  • Dietary Supplement: Micronutrient Supplement, capsule form

    18 mg beta-carotene 500 mg vitamin C (delivered as 500 mg ascorbic acid) 270 mg vitamin E (delivered as 305 mg alpha-tocopherol acetate) 315 mg magnesium (delivered as 1949 mg magnesium citrate)

    All substances will be given to subjects orally in capsule form. The total daily dose will be divided into two equal half-doses, and the half doses will be consumed for two consecutive days (cross-over studies).

    Other Name: Auraquell
  • Other: Placebo, capsule form

    Inert

    Inert placebo control will be given to subjects orally in capsule form; capsules appear identical to active agent capsules with respect to both shape and color. Capsules will be consumed as two equal "half-doses," on a time-schedule that is identical to active agent treatments. Half doses will be consumed for two consecutive days (cross-over studies).

  • Drug: Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium

    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.

    Other Name: Soundbites®
  • Other: Placebo Control
    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.
  • Experimental: Experimental Agent
    Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
    Intervention: Drug: Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium
  • Placebo Comparator: Placebo
    Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
    Intervention: Other: Placebo Control
  • Experimental: Experimental Agent, Cross-over
    Subjects in short-term study in Sweden; subjects are treated with active agents in one arm of the study. Capsule-based treatments are delivered for two days. Subjects also participate in placebo arm, and order of treatments is masked.
    Intervention: Dietary Supplement: Micronutrient Supplement, capsule form
  • Placebo Comparator: Placebo, cross-over
    Subjects in short-term study in Sweden; subjects receive placebo capsules in one arm of the study. Subjects also participate in treated arm, and order of treatments is masked.
    Intervention: Other: Placebo, capsule form

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Hearing inclusion criteria are as follows for all studies:

  • subjects must have a normal audiologic assessment at baseline consisting of:

    1. symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
    2. no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
    3. no significant air-bone gaps (i.e., greater than 10 dB); and
    4. 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

Exclusion Criteria:

  • 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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Sweden
 
NCT00808470
U01DC008423, U01DC008423-02S1, U01DC008423-03, U01DC008423
Yes
Josef M Miller, University of Michigan
University of Michigan
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Florida
  • Karolinska Institutet
  • Southern Illinois University
  • Hearing Health Science Inc (clinical supply funding: mint tablets)
  • OtoMedicine Inc (clinical supply funding: capsules)
Principal Investigator: Josef M Miller, PhD University of Michigan
Principal Investigator: Colleen G Le Prell, PhD University of Florida
University of Michigan
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP