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Micronutrients to Prevent Noise-induced Hearing Loss

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ClinicalTrials.gov Identifier: NCT00808470
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (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
Enrollment 72

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 37 35
Completed 35 35
Not Completed 2 0
Arm/Group Title Nutrients Placebo for Nutrients Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 37 35 72
Hide Baseline Analysis Population Description
healthy young adults that meet audiometric enrollment criteria
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 35 participants 72 participants
22.0  (2.4) 21.3  (2.4) 21.6  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 35 participants 72 participants
Female
17
  45.9%
15
  42.9%
32
  44.4%
Male
20
  54.1%
20
  57.1%
40
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 35 participants 72 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 35 participants 72 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 35 participants 72 participants
37 35 72
1.Primary Outcome
Title Average Threshold Shift at 4 kHz in Both Ears
Hide Description 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.
Time Frame 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure.
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: decibels
15 minutes post exposure 3.94  (4.39) 3.4  (3.81)
1 hour and 15 minutes after exposure 2.77  (4.00) 2.03  (3.12)
2 hours and 15 minutes after exposure 2.27  (3.81) 2.03  (3.12)
3 hours and 15 minutes after exposure 1.51  (3.18) .88  (2.48)
1 day after exposure .09  (1.91) .00  (1.91)
1 week after exposure -.57  (2.25) .11  (2.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nutrients, Placebo for Nutrients
Comments 15 minutes after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nutrients, Placebo for Nutrients
Comments 1 hour and 15 minutes after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nutrients, Placebo for Nutrients
Comments 2 Hours 15 minutes after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .51
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nutrients, Placebo for Nutrients
Comments 3 hours, 15 minutes after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Nutrients, Placebo for Nutrients
Comments 1 day after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .86
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nutrients
Comments 1 week after exposure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .24
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music
Hide Description 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.
Time Frame 15 min
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants that completed music exposure were assessed; two participants withdrew prior to music exposure.
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description:

Dietary Supplement. Subjects in UF 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.

Subjects in UF 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.

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: decibels
250 Hz 0.2571  (0.3487) 1.2286  (0.4921)
500 Hz 0.8  (0.4177) 1.0000  (0.3932)
1000 Hz 1.6571  (0.4119) 1.6857  (0.4505)
2000 Hz 1.9429  (0.6403) 1.9143  (0.4365)
3000 Hz 3.0286  (0.7944) 2.7714  (0.5219)
6000 Hz 2.2286  (0.4203) 2.1143  (0.4579)
8000 Hz 0.6286  (0.4474) 1.0000  (0.5266)
3.Secondary Outcome
Title Tinnitus
Hide Description Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants completing music exposure completed tinnitus surveys.
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: participants
11 6
4.Other Pre-specified Outcome
Title Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes
Hide Description DPOAE amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. Test time was approximate as DPOAE tests began as soon as threshold testing was completed. F1 and F2 frequency pairs included 3328 and 3984 Hz, F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. Threshold tests take approximately 15 min, but the exact duration of testing varies from subject to subject. The OAE testing began as soon as threshold testing completed. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier or a little bit later (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).
Time Frame 15 min
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for one participant in the placebo group is incomplete.
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description:

beta-carotene, vitamins C and E, magnesium

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.

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

Placebo: 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.

Overall Number of Participants Analyzed 35 34
Mean (Standard Deviation)
Unit of Measure: decibels (dB)
f2=3984Hz,f1=65dB,right 3.9  (9.3) 6.6  (6.5)
f2=3984Hz,f1=60dB,right 0.9  (8.9) 5.1  (4.6)
f2=3984Hz,f1=55dB,right -3.3  (8.8) 0.5  (6.0)
f2=3984Hz,f1=50dB,right -7.8  (9.6) -4.2  (7.0)
f2=3984Hz,f1=45dB,right -13.9  (9.8) -10.4  (7.7)
f2=3984Hz,f1=40dB,right -19.7  (12.8) -15.6  (8.6)
f2=3984Hz,f1=35dB,right -23.8  (8.3) -21.1  (9.6)
f2=3984Hz,f1=30dB,right -25.5  (10.2) -26.8  (9.7)
f2=3984Hz,f1=25dB,right -26.4  (10.6) -28.0  (11.1)
f2=3984Hz,f1=65dB,left 4.4  (8.1) 4.3  (10.1)
f2=3984Hz,f1=60dB,left 1.8  (6.5) 1.3  (8.5)
f2=3984Hz,f1=55dB,left -2.7  (6.8) -1.3  (7.6)
f2=3984Hz,f1=50dB,left -7.0  (7.3) -7.7  (9.6)
f2=3984Hz,f1=45dB,left -13.6  (7.6) -12.2  (10.2)
f2=3984Hz,f1=40dB,left -18.6  (8.7) -19.2  (10.1)
f2=3984Hz,f1=35dB,left -22.1  (12.8) -23.6  (8.8)
f2=3984Hz,f1=30dB,left -30.9  (8.2) -27.1  (9.0)
f2=3984Hz,f1=25dB,left -32.2  (7.7) -29.8  (8.2)
5.Other Pre-specified Outcome
Title Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz
Hide Description [Not Specified]
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.
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures
Hide Description DPOAE amplitude was measured following the audiometric testing completion at each of the post-music test times. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 3328 and 3984 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels.
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.
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs
Hide Description Distortion Product Otoacoustic Emission (DPOAE) Amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10dB lower than F1 Levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. The OAE testing began as soon as threshold testing completed. Threshold tests take approximately 15 min, but the exact duration of testing varies among subjects. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier than for others (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).
Time Frame 15 minutes
Outcome Measure Data Not Reported
Time Frame one week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nutrients Placebo for Nutrients
Hide Arm/Group Description

Dietary Supplement. Subjects in UF 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.

Subjects in UF 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.

All-Cause Mortality
Nutrients Placebo for Nutrients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nutrients Placebo for Nutrients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nutrients Placebo for Nutrients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/37 (5.41%)      5/35 (14.29%)    
Gastrointestinal disorders     
Stomach ache  [1]  1/37 (2.70%)  1 2/35 (5.71%)  2
Diarrhea   1/37 (2.70%)  1 3/35 (8.57%)  3
Indicates events were collected by systematic assessment
[1]
includes any report of stomach ache, upset stomach,
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
Responsible Party: Glenn Green, University of Michigan
ClinicalTrials.gov Identifier: NCT00808470     History of Changes
Other Study ID Numbers: U01DC008423 ( U.S. NIH Grant/Contract )
U01DC008423-02S1 ( U.S. NIH Grant/Contract )
U01DC008423-03 ( U.S. NIH Grant/Contract )
U01DC008423 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2008
First Posted: December 15, 2008
Results First Submitted: May 8, 2015
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017