Trial record 9 of 12 for:    tinnitus | Exclude Unknown | NIH

Micronutrients to Prevent Noise-induced Hearing Loss

This study has been completed.
Sponsor:
Collaborators:
University of Florida
Karolinska Institutet
Southern Illinois University
Hearing Health Science Inc (clinical supply funding: mint tablets)
OtoMedicine Inc (clinical supply funding: capsules)
Information provided by (Responsible Party):
Josef M Miller, University of Michigan
ClinicalTrials.gov Identifier:
NCT00808470
First received: December 11, 2008
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.

Experiment 2: "Urban warfare" military studies (Karolinska Institutet, Sweden). Prevention of *temporary* elevations in hearing thresholds, induced by automatic gunfire sound inside a concrete bunker, will be measured. Subjects will be 31 adult male or female officers in the Swedish army required to participate in urban combat training regardless of study participation. All subjects are required to wear standard hearing protection during combat exercises.


Condition Intervention Phase
Noise-Induced Hearing Loss
Dietary Supplement: Micronutrient Supplement, capsule form
Other: Placebo, capsule form
Drug: Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium
Other: Placebo Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Micronutrient Intervention to Reduce Noise-Induced Hearing Loss: Prevention of Temporary Threshold Changes Induced by Use of a Digital Music Player

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Average threshold shift at 4 kHz in both ears [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Threshold shift at individual frequencies, including 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12.5, 14 and 16 kHz [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
  • Distortion Product Otoacoustic Emission (DPOAE) amplitude [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]
  • Tinnitus [ Time Frame: 15 min, repeated measures at 1-1.5 hr intervals for 3-3.5 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: October 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Agent
Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.
Drug: Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium

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.

Other Name: Soundbites®
Placebo Comparator: Placebo
Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.
Other: Placebo Control
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.
Experimental: Experimental Agent, Cross-over
Subjects in short-term study in Sweden; subjects are treated with active agents in one arm of the study. Capsule-based treatments are delivered for two days. Subjects also participate in placebo arm, and order of treatments is masked.
Dietary Supplement: Micronutrient Supplement, capsule form

18 mg beta-carotene 500 mg vitamin C (delivered as 500 mg ascorbic acid) 270 mg vitamin E (delivered as 305 mg alpha-tocopherol acetate) 315 mg magnesium (delivered as 1949 mg magnesium citrate)

All substances will be given to subjects orally in capsule form. The total daily dose will be divided into two equal half-doses, and the half doses will be consumed for two consecutive days (cross-over studies).

Other Name: Auraquell
Placebo Comparator: Placebo, cross-over
Subjects in short-term study in Sweden; subjects receive placebo capsules in one arm of the study. Subjects also participate in treated arm, and order of treatments is masked.
Other: Placebo, capsule form

Inert

Inert placebo control will be given to subjects orally in capsule form; capsules appear identical to active agent capsules with respect to both shape and color. Capsules will be consumed as two equal "half-doses," on a time-schedule that is identical to active agent treatments. Half doses will be consumed for two consecutive days (cross-over studies).


  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Hearing inclusion criteria are as follows for all studies:

  • subjects must have a normal audiologic assessment at baseline consisting of:

    1. symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
    2. no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
    3. no significant air-bone gaps (i.e., greater than 10 dB); and
    4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808470

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sweden
Karolinksa Institutet
Stockholm, Sweden, 171 76
Sponsors and Collaborators
University of Michigan
University of Florida
Karolinska Institutet
Southern Illinois University
Hearing Health Science Inc (clinical supply funding: mint tablets)
OtoMedicine Inc (clinical supply funding: capsules)
Investigators
Principal Investigator: Josef M Miller, PhD University of Michigan
Principal Investigator: Colleen G Le Prell, PhD University of Florida
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josef M Miller, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00808470     History of Changes
Other Study ID Numbers: U01DC008423, U01DC008423-02S1, U01DC008423-03, U01DC008423
Study First Received: December 11, 2008
Last Updated: January 23, 2014
Health Authority: United States: Federal Government (National Institutes of Health: National Institute on Deafness and Other Communication Disorders)
United States: Food and Drug Administration
United States: Institutional Review Board (University of Florida IRB-01 Approval #560-2009)
Sweden: Regional Ethical Review Board

Keywords provided by University of Michigan:
Noise
Hearing Loss
Tinnitus
Antioxidant
Vasodilator
Beta-Carotene
Vitamin C
Vitamin E
Magnesium

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural
Ascorbic Acid
Carotenoids
Vitamins
Beta Carotene
Micronutrients
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances

ClinicalTrials.gov processed this record on August 21, 2014