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Fish Oil to Prevent Asthma Exacerbations in Patients With ALOX5 Polymorphisms
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study is a single-center, investigator-initiated, randomized, double-blind, placebo-controlled, cross-over trial. A total of 30 subjects will be recruited from the U.C. Davis Asthma Network (UCAN) clinics. Some of the research will be conducted at the USDA-WHNRC (Western Health Nutrition Research Center) here at U.C. Davis.
This clinical trial is designed to study the effects of supplemental intake of eicosapentanoic acid (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA, fish oil) in a subset of moderate to severe asthmatics, who have a high susceptibility to increased leukotriene production due to a polymorphism in the promoter region of the arachidonate 5-lipoxygenase (ALOX5) gene.
EPA competes with AA and can decrease leukotriene production; thus our central hypothesis is that EPA-enriched n3-PUFA supplements will decrease the production of inflammatory leukotrienes and decrease the number of acute exacerbations of asthma in patients with moderate to severe asthma and that these benefits will be greater in subjects with the "high susceptibility" ALOX5 promoter variants. Our specific aims are to: 1) Determine the prevalence of the "high-susceptibility" ALOX5 pathway gene polymorphisms in a diverse cohort of moderate to severe adult asthmatics, 2) Perform a 32 week (12 wk treatment A - 8 wk washout - 12 wk treatment B), blinded, cross-over design clinical trial, during which we treat 15 "high susceptibility" and 15 "low susceptibility" ALOX5 gene polymorphism asthmatics with n-3 PUFA supplements and placebo, and 3) Determine the baseline level and treatment effect of n-3 PUFA supplements on leukotriene metabolite and inflammatory cytokine production in subjects with the 'high' and 'low' susceptibility genotypes. Patients will be recruited primarily from the UC Davis Asthma Network (UCAN).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Mather, California, Verenigde Staten, 95655
- Ucdmc/Vanchcs Ccrc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 1
"High" susceptibility ALOX5 gene polymorphisms.
Patients will be classified as having high susceptibility ALOX5 gene polymorphisms based on the number of repeats of the SP1 promoter.
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Subjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.
Andere namen:
Subjects will take a Placebo capsule for 90 days, followed by an 8 week washout period, and then will take the (EPA)-enriched omega-3 polyunsaturated fatty acids supplements as a capsule (3-4 g of EPA/day) for 90 days.
Andere namen:
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Actieve vergelijker: 2
"Low" susceptibility ALOX5 gene polymorphisms.
"Low" susceptibility ALOX5 gene polymorphisms.
Patients will be classified as having high susceptibility ALOX5 gene polymorphisms based on the number of repeats of the SP1 promoter.
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Subjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.
Andere namen:
Subjects will take a Placebo capsule for 90 days, followed by an 8 week washout period, and then will take the (EPA)-enriched omega-3 polyunsaturated fatty acids supplements as a capsule (3-4 g of EPA/day) for 90 days.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Asthma exacerbations
Tijdsspanne: 3 months
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3 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nicholas Kenyon, MD, University of California, Davis
- Studie directeur: Charles Stephensen, Ph.D., USDA, Staff Scientist
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 200715569
- CHNR07702 (Andere identificatie: Other)
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Klinische onderzoeken op EPA enriched fish oils
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Leiden University Medical CenterAtrium InnovationsVoltooidPsychiatrische ziekenhuisopnameNederland