Micronutrients to Prevent Noise-induced Hearing Loss
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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
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