Micronutrients to Prevent Noise-induced Hearing Loss
Condition: Noise-Induced Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Noise-Induced
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): beta-carotene, vitamins C and E, magnesium; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): Soundbites®
Intervention MeSH terms: Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Noise; Hearing Loss; Tinnitus; Antioxidant; Vasodilator; Beta-Carotene; Vitamin C; Vitamin E; Magnesium