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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00621829 |
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Date of registration:
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12/02/2008 |
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Primary sponsor: |
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Public title:
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Fish Oil to Prevent Asthma Exacerbations in Patients With ALOX5 Polymorphisms
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Scientific title:
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Pilot Study of Supplemental Eicosapentanoic Acid (EPA)-Enriched Omega-3 Polyunsaturated Fatty Acids (n3-PUFA) in a Subset of Moderate to Severe Asthmatics With Polymorphisms of the Arachidonate 5-lipoxygenase (ALOX5) Gene |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00621829 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nicholas Kenyon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Name:
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Charles Stephensen, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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USDA, Staff Scientist |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children and adults patients >18 years or older with moderate and severe asthma (as
diagnosed by lung specialist physician), based on the NIH NAEPP 1997 guidelines, who
do not have an acute exacerbation at the time of enrollment and are on the same
asthma medications for at least 1 month
Exclusion Criteria:
- Less than 18 years of age
- Baseline FEV1 < 35% predicted
- Known or suspected allergy to fish oil products
- Pregnant women and nursing women
- Current smokers or subjects with a 20 pack-year history of smoking
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Dietary Supplement: EPA enriched fish oils
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Primary Outcome(s)
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Asthma exacerbations
[Time Frame: 3 months]
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Secondary ID(s)
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CHNR07702
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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