Micronutrients to Prevent Noise-induced Hearing Loss

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Collaborators: Hearing Health Science Inc (clinical supply funding: mint tablets); Hearing Health Science, Inc.; Karolinska Institutet; National Institute on Deafness and Other Communication Disorders (NIDCD); OtoMedicine Inc (clinical supply funding: capsules); Southern Illinois University; University of Florida
• Treatments: Ascorbic Acid; Beta Carotene; Carotenoids; Magnesium citrate; Micronutrients; Trace Elements; Vitamin E; Vitamins

Criteria

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