Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=72 Randomized Quadruple-blind Prevention

Micronutrients to Prevent Noise-induced Hearing Loss

Noise-Induced Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT00808470 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Average Threshold Shift at 4 kHz in Both Ears — 3.94; 3.4; 2.77; 2.03 decibels — p=0.58

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
beta-carotene, vitamins C and E, magnesium (Drug); Placebo (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Average Threshold Shift at 4 kHz in Both Ears		 3.94; 3.4; 2.77; 2.03; 2.27; 2.03 0.58
SECONDARY
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music		 0.2571; 1.2286; 0.8; 1.0000; 1.6571; 1.6857 —
SECONDARY
Tinnitus		 11; 6 —

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.

Eligibility Criteria

Inclusion Criteria

Hearing inclusion criteria are as follows for all studies:

  • subjects must have a normal audiologic assessment at baseline consisting of:
  • symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
  • no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
  • no significant air-bone gaps (i.e., greater than 10 dB); and
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00808470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search