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NCT00808470 · ClinicalTrials.gov registry record · Phase 2
Micronutrients to Prevent Noise-induced Hearing Loss
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT00808470: Completed Phase 2 study, sponsored by University of Michigan.
NCT00808470 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00808470, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.
Interventions
- OTHER Placebo
- DRUG beta-carotene, vitamins C and E, magnesium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00808470 record still lists
NCT00808470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00808470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00808470 about?
NCT00808470 is a clinical study titled "Micronutrients to Prevent Noise-induced Hearing Loss". 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 combinatio...
What is the current status of trial NCT00808470?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2008-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00808470?
The interventions under investigation include: Placebo (OTHER), beta-carotene, vitamins C and E, magnesium (DRUG).
Who is sponsoring clinical trial NCT00808470?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00808470's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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