Trial Outcomes & Findings for Micronutrients to Prevent Noise-induced Hearing Loss (NCT NCT00808470)

Last Updated: 2017-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Results posted on

2017-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	37	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Micronutrients to Prevent Noise-induced Hearing Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nutrients n=37 Participants 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 n=35 Participants 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 n=72 Participants Total of all reporting groups
Age, Continuous	22.0 years STANDARD_DEVIATION 2.4 • n=5 Participants	21.3 years STANDARD_DEVIATION 2.4 • n=7 Participants	21.6 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	35 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Population: All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure.

Outcome measures

Outcome measures
Measure	Nutrients n=35 Participants 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 n=35 Participants 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.
Average Threshold Shift at 4 kHz in Both Ears 1 hour and 15 minutes after exposure	2.77 decibels Standard Deviation 4.00	2.03 decibels Standard Deviation 3.12
Average Threshold Shift at 4 kHz in Both Ears 15 minutes post exposure	3.94 decibels Standard Deviation 4.39	3.4 decibels Standard Deviation 3.81
Average Threshold Shift at 4 kHz in Both Ears 2 hours and 15 minutes after exposure	2.27 decibels Standard Deviation 3.81	2.03 decibels Standard Deviation 3.12
Average Threshold Shift at 4 kHz in Both Ears 3 hours and 15 minutes after exposure	1.51 decibels Standard Deviation 3.18	.88 decibels Standard Deviation 2.48
Average Threshold Shift at 4 kHz in Both Ears 1 day after exposure	.09 decibels Standard Deviation 1.91	.00 decibels Standard Deviation 1.91
Average Threshold Shift at 4 kHz in Both Ears 1 week after exposure	-.57 decibels Standard Deviation 2.25	.11 decibels Standard Deviation 2.25

SECONDARY outcome

Timeframe: 15 min

Population: all participants that completed music exposure were assessed; two participants withdrew prior to music exposure.

Outcome measures

Outcome measures
Measure	Nutrients n=35 Participants 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 n=35 Participants 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.
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 250 Hz	0.2571 decibels Standard Deviation 0.3487	1.2286 decibels Standard Deviation 0.4921
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 500 Hz	0.8 decibels Standard Deviation 0.4177	1.0000 decibels Standard Deviation 0.3932
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 1000 Hz	1.6571 decibels Standard Deviation 0.4119	1.6857 decibels Standard Deviation 0.4505
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 2000 Hz	1.9429 decibels Standard Deviation 0.6403	1.9143 decibels Standard Deviation 0.4365
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 3000 Hz	3.0286 decibels Standard Deviation 0.7944	2.7714 decibels Standard Deviation 0.5219
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 6000 Hz	2.2286 decibels Standard Deviation 0.4203	2.1143 decibels Standard Deviation 0.4579
Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music 8000 Hz	0.6286 decibels Standard Deviation 0.4474	1.0000 decibels Standard Deviation 0.5266

SECONDARY outcome

Timeframe: immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Population: all participants completing music exposure completed tinnitus surveys.

Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.

Outcome measures

Outcome measures
Measure	Nutrients n=35 Participants 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 n=35 Participants 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.
Tinnitus	11 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 min

Population: Data for one participant in the placebo group is incomplete.

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).

Outcome measures

Outcome measures
Measure	Nutrients n=35 Participants 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 n=34 Participants 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.
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=65dB,right	3.9 decibels (dB) Standard Deviation 9.3	6.6 decibels (dB) Standard Deviation 6.5
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=60dB,right	0.9 decibels (dB) Standard Deviation 8.9	5.1 decibels (dB) Standard Deviation 4.6
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=55dB,right	-3.3 decibels (dB) Standard Deviation 8.8	0.5 decibels (dB) Standard Deviation 6.0
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=50dB,right	-7.8 decibels (dB) Standard Deviation 9.6	-4.2 decibels (dB) Standard Deviation 7.0
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=45dB,right	-13.9 decibels (dB) Standard Deviation 9.8	-10.4 decibels (dB) Standard Deviation 7.7
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=40dB,right	-19.7 decibels (dB) Standard Deviation 12.8	-15.6 decibels (dB) Standard Deviation 8.6
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=35dB,right	-23.8 decibels (dB) Standard Deviation 8.3	-21.1 decibels (dB) Standard Deviation 9.6
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=30dB,right	-25.5 decibels (dB) Standard Deviation 10.2	-26.8 decibels (dB) Standard Deviation 9.7
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=25dB,right	-26.4 decibels (dB) Standard Deviation 10.6	-28.0 decibels (dB) Standard Deviation 11.1
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=65dB,left	4.4 decibels (dB) Standard Deviation 8.1	4.3 decibels (dB) Standard Deviation 10.1
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=60dB,left	1.8 decibels (dB) Standard Deviation 6.5	1.3 decibels (dB) Standard Deviation 8.5
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=55dB,left	-2.7 decibels (dB) Standard Deviation 6.8	-1.3 decibels (dB) Standard Deviation 7.6
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=50dB,left	-7.0 decibels (dB) Standard Deviation 7.3	-7.7 decibels (dB) Standard Deviation 9.6
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=45dB,left	-13.6 decibels (dB) Standard Deviation 7.6	-12.2 decibels (dB) Standard Deviation 10.2
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=40dB,left	-18.6 decibels (dB) Standard Deviation 8.7	-19.2 decibels (dB) Standard Deviation 10.1
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=35dB,left	-22.1 decibels (dB) Standard Deviation 12.8	-23.6 decibels (dB) Standard Deviation 8.8
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=30dB,left	-30.9 decibels (dB) Standard Deviation 8.2	-27.1 decibels (dB) Standard Deviation 9.0
Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes f2=3984Hz,f1=25dB,left	-32.2 decibels (dB) Standard Deviation 7.7	-29.8 decibels (dB) Standard Deviation 8.2

OTHER_PRE_SPECIFIED outcome

Timeframe: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 minutes

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).

Outcome measures

Outcome data not reported

Adverse Events

Nutrients

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo for Nutrients

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nutrients n=37 participants at risk 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.	Placebo for Nutrients n=35 participants at risk 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.
Gastrointestinal disorders Stomach ache	2.7% 1/37 • Number of events 1 • one week	5.7% 2/35 • Number of events 2 • one week
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Number of events 1 • one week	8.6% 3/35 • Number of events 3 • one week

Additional Information

Dr. Colleen Le Prell

University of Texas at Dallas

Phone: 214-905-3018

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place