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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 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 72 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00808470
The ClinicalTrials.gov registry entry for NCT00808470 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00808470 reports 0 study locations.
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.
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