Antioxidation Medication for Noise-induced Hearing Loss
NCT ID: NCT00552786
Last Updated: 2010-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2007-11-30
2008-03-31
Brief Summary
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Detailed Description
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The 53 noise-exposed workers from steel industries in Taiwan will be recruited, and divided into N-Acetylcysteine (NAC)(Acetine, 1200mg/day) group and placebo one. The duration of medication is 2 weeks initially. After washout for 2 weeks, the kinds of medications in these 2 groups will be crossover and used for 2 weeks. Firstly, questionnaires interview about noise exposure, smoking, alcohol drinking, drug habit history and calculation of Body Mass Index (BMI) will be done. The following methods would be performed individually after medication. With detailed local examination with otoscope, these subjects receive hearing tests by pure-tone audiometry (PTA) and distortion product otoacoustic emissions (DPOAE) before and after their daily works. The possible confounding factors including background noise, solvent, heavy metals, carbon monoxide and temperature in the workplaces will be assessed. The amount of noise exposure is evaluated by personal dosimeter. Early morning, Blood samples will be collected. Deletion polymorphisms in the Glutathione S-transferase (GST)T1 and GSTM1 genes will be determined. Statistical analysis will be performed to evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal threshold shift (TTS).
The expected results of this study are to determine whether anti-oxidant supplements protect workers from noise-induced TTS.
We anticipate that these human studies might help elucidate the relative importance of anti-oxidant enzymes as risk factors for NIHL.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Acetin
N-acetylcysteine (NAC)
600mg twice daily for 2 weeks
Glucose
glucose
1 gm glucose capsule
Interventions
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N-acetylcysteine (NAC)
600mg twice daily for 2 weeks
glucose
1 gm glucose capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* known exposure to noise at work
Exclusion Criteria
* fasting glucose of 120 or greater
25 Years
65 Years
MALE
Yes
Sponsors
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Institute of Occupational Safety and Health, Taiwan
UNKNOWN
Municipal Hospital of Tainan, Taiwan
UNKNOWN
National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University
Principal Investigators
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Yue-Liang L Guo, MD, MPH, PHD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Tung-Sheng Shih, PHD
Role: STUDY_DIRECTOR
Institute of Occupational Safety and Health, Taiwan
Locations
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Environmental and Occupational Medicine, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Coleman JK, Kopke RD, Liu J, Ge X, Harper EA, Jones GE, Cater TL, Jackson RL. Pharmacological rescue of noise induced hearing loss using N-acetylcysteine and acetyl-L-carnitine. Hear Res. 2007 Apr;226(1-2):104-13. doi: 10.1016/j.heares.2006.08.008. Epub 2006 Oct 4.
Kopke R, Bielefeld E, Liu J, Zheng J, Jackson R, Henderson D, Coleman JK. Prevention of impulse noise-induced hearing loss with antioxidants. Acta Otolaryngol. 2005 Mar;125(3):235-43. doi: 10.1080/00016480410023038.
Duan M, Qiu J, Laurell G, Olofsson A, Counter SA, Borg E. Dose and time-dependent protection of the antioxidant N-L-acetylcysteine against impulse noise trauma. Hear Res. 2004 Jun;192(1-2):1-9. doi: 10.1016/j.heares.2004.02.005.
Kopke RD, Jackson RL, Coleman JK, Liu J, Bielefeld EC, Balough BJ. NAC for noise: from the bench top to the clinic. Hear Res. 2007 Apr;226(1-2):114-25. doi: 10.1016/j.heares.2006.10.008. Epub 2006 Dec 20.
Lin CY, Wu JL, Shih TS, Tsai PJ, Sun YM, Ma MC, Guo YL. N-Acetyl-cysteine against noise-induced temporary threshold shift in male workers. Hear Res. 2010 Oct 1;269(1-2):42-7. doi: 10.1016/j.heares.2010.07.005. Epub 2010 Jul 16.
Other Identifiers
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200704018M
Identifier Type: -
Identifier Source: org_study_id
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