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| Sponsors and Collaborators: |
National Institute on Deafness and Other Communication Disorders (NIDCD) Karolinska Institutet Southern Illinois University University of Castilla-La Mancha University of Florida University of Michigan |
|---|---|
| Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| ClinicalTrials.gov Identifier: | NCT00808470 |
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 antioxidants (beta-carotene, and vitamins C and E) and the mineral magnesium (which acts in part as a vasodilator) 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 60 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 24 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.
Experiment 3: "NATO airbase" studies (Universidad de Castilla-La Mancha, Spain). Prevention of permanent hearing loss, induced by daily exposure to aircraft engine noise, will be measured over two-years. Subjects will be 120 adult male or female Spanish NATO soldiers. All subjects are required to wear standard hearing protection regardless of study participation.
Experiment 4: "Stamping Factory" studies (Universidad de Castilla-La Mancha, Spain). Prevention of permanent hearing loss, induced by daily exposure to industrial noise, will be will be measured over two-years. Subjects will be 120 adult male or female personnel at a Spanish stamping factory hired within the past 5 years. All subjects are required to wear standard hearing protection regardless of study participation.
| Condition | Intervention | Phase |
|---|---|---|
|
Noise-Induced Hearing Loss |
Dietary Supplement: Micronutrient Supplement Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Phase II Study of Efficacy of Antioxidants and Vasodilator to Reduced Noise-Induced Hearing Loss |
| Estimated Enrollment: | 324 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental Agent, Two-year: Experimental
Subjects in two-year studies in Spain who are assigned to treatment group in either Airbase or Factory populations.
|
Dietary Supplement: Micronutrient Supplement
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) or daily, for two years. |
|
Placebo, Two-year: Placebo Comparator
Subjects in two-year studies in Spain who are assigned to control condition in either Airbase or Factory populations.
|
Other: Placebo
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) or daily, for two years. |
|
Experimental Agent, Cross-over: Experimental
Subjects in short-term studies in Sweden and the United States; all subjects are treated with active agents in one arm of the study. All subjects also participate in placebo arm, and order of treatments is masked.
|
Dietary Supplement: Micronutrient Supplement
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) or daily, for two years. |
|
Placebo, cross-over: Placebo Comparator
Subjects in short-term studies in Sweden and the United States; all subjects are treated with placebo agents in one arm of the study. All subjects also participate in treated arm, and order of treatments is masked.
|
Other: Placebo
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) or daily, for two years. |
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Hearing inclusion criteria are as follows for all studies:
subjects must have a normal audiologic assessment at baseline consisting of:
Additional criteria are as follows:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Florida | Not yet recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Colleen G Le Prell, PhD 352-271-6163 colleeng@phhp.ufl.edu | |
| Principal Investigator: Colleen G Le Prell, PhD | |
| Sub-Investigator: James W Hall, PhD | |
| Sub-Investigator: Patrick J Antonelli | |
| Spain, LaMancha | |
| Universidad de Castille-LaMancha | Not yet recruiting |
| Albacete, LaMancha, Spain, 02006 | |
| Contact: Luis Gonzalez, MD 34 0780 5908 lgonzalezf@solimat.com | |
| Contact: Julio Carbayo 967 24 78 43 jacarbayoh@telefonica.net | |
| Principal Investigator: Jose M Juiz, MD-PhD | |
| Sub-Investigator: Julio Carbayo, MD | |
| Sweden | |
| Karolinksa Institutet | Recruiting |
| Stockholm, Sweden, 171 76 | |
| Contact: Ann-Cathrine Lindblad, MS 08-5858 0148 Anncat.Lindblad@ki.se | |
| Principal Investigator: Mats Ulfendahl, PhD | |
| Sub-Investigator: Ulf Rosenhall, MD | |
| Principal Investigator: | Josef M Miller, PhD | University of Michigan |
| Study Director: | Colleen G Le Prell, PhD | University of Florida |
More Information
| Responsible Party: | NIH-NIDCD ( Gordon Hughes/Program Director, Clinical Trials ) |
| Study ID Numbers: | UO1DC008423, UO1DC008423 |
| Study First Received: | December 11, 2008 |
| Last Updated: | December 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00808470 History of Changes |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board; Spain: Comité Ético de Investigación Clínica; Sweden: Regional Ethical Review Board |
|
Noise Hearing Loss Tinnitus Antioxidant Vasodilator |
Beta-Carotene Vitamin C Vitamin E Magnesium |
|
Sensation Disorders Vasodilator Agents Beta Carotene Antioxidants Retrocochlear Diseases Sensorineural Hearing Loss Hearing Loss, Sensorineural Ear Diseases Tinnitus Tocopherols Signs and Symptoms Hearing Disorders Hearing Loss, Noise-Induced Deafness Vitamins |
Magnesium citrate Tocotrienols Micronutrients Hearing Loss Tocopherol acetate Otorhinolaryngologic Diseases Citric Acid Trace Elements Cardiovascular Agents Alpha-Tocopherol Vitamin E Neurologic Manifestations Carotenoids Ascorbic Acid |
|
Sensation Disorders Vasodilator Agents Otorhinolaryngologic Diseases Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Retrocochlear Diseases Nervous System Diseases Trace Elements Cardiovascular Agents Hearing Loss, Sensorineural |
Protective Agents Ear Diseases Pharmacologic Actions Signs and Symptoms Deafness Hearing Loss, Noise-Induced Hearing Disorders Therapeutic Uses Neurologic Manifestations Micronutrients Hearing Loss |
