Micronutrients to Prevent Noise-induced Hearing Loss

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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This study assessed the potential for prevention of the temporary changes in hearing that can occur after use of a music player device for 4 hours. All participants listened to one of two playlists (pop or rock) set at the same volumes to provide equivalent and consistent exposures across participants. Participants received either a dietary supplement or a placebo once/daily for three days prior to the day of music exposure, and also on the day of music exposure. The fourth and final dose was consumed immediately prior to music listening and consumption was observed by a member of the study team. Changes in hearing were assessed 15-min post-music, and then 1, 2, and 3 hours later, as well as the following day and 1 week later.

Conditions

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Noise-Induced Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nutrients

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.

Group Type EXPERIMENTAL

beta-carotene, vitamins C and E, magnesium

Intervention Type DRUG

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.

Placebo for nutrients

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

Placebo

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.

Intervention Type OTHER

Other Intervention Names

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Soundbites®

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes