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Micronutrients to Prevent Noise-induced Hearing Loss

This study has been completed.
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Florida
Southern Illinois University
Hearing Health Science, Inc.
Information provided by (Responsible Party):
Glenn Green, University of Michigan
ClinicalTrials.gov Identifier:
NCT00808470
First received: December 11, 2008
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Prevention
Condition: Noise-Induced Hearing Loss
Interventions: Drug: beta-carotene, vitamins C and E, magnesium
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nutrients

Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.

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.

Placebo for Nutrients

Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.

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.


Participant Flow:   Overall Study
    Nutrients   Placebo for Nutrients
STARTED   37   35 
COMPLETED   35   35 
NOT COMPLETED   2   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
healthy young adults that meet audiometric enrollment criteria

Reporting Groups
  Description
Nutrients

Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.

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.

Placebo for Nutrients

Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.

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.

Total Total of all reporting groups

Baseline Measures
   Nutrients   Placebo for Nutrients   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   35   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.0  (2.4)   21.3  (2.4)   21.6  (2.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  45.9%      15  42.9%      32  44.4% 
Male      20  54.1%      20  57.1%      40  55.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      10  27.0%      10  28.6%      20  27.8% 
Not Hispanic or Latino      26  70.3%      25  71.4%      51  70.8% 
Unknown or Not Reported      1   2.7%      0   0.0%      1   1.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      4  10.8%      3   8.6%      7   9.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   5.4%      2   5.7%      4   5.6% 
White      25  67.6%      26  74.3%      51  70.8% 
More than one race      3   8.1%      4  11.4%      7   9.7% 
Unknown or Not Reported      3   8.1%      0   0.0%      3   4.2% 
Region of Enrollment 
[Units: Participants]
     
United States   37   35   72 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Threshold Shift at 4 kHz in Both Ears   [ Time Frame: 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]

2.  Secondary:   Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music   [ Time Frame: 15 min ]

3.  Secondary:   Tinnitus   [ Time Frame: immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]

4.  Other Pre-specified:   Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes   [ Time Frame: 15 min ]

5.  Other Pre-specified:   Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz   [ Time Frame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures   [ Time Frame: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs   [ Time Frame: 15 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Colleen Le Prell
Organization: University of Texas at Dallas
phone: 214-905-3018
e-mail: colleen.leprell@utdallas.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Glenn Green, University of Michigan
ClinicalTrials.gov Identifier: NCT00808470     History of Changes
Other Study ID Numbers: U01DC008423 ( US NIH Grant/Contract Award Number )
U01DC008423-02S1 ( US NIH Grant/Contract Award Number )
U01DC008423-03 ( US NIH Grant/Contract Award Number )
Study First Received: December 11, 2008
Results First Received: May 8, 2015
Last Updated: April 13, 2017