Fish Oil to Prevent Asthma Exacerbations in Patients With ALOX5 Polymorphisms
Completed · Not applicable · Has a placebo group
Conditions studied: Asthma
In brief
This is a clinical study that is designed to study the effects of the supplemental intake of enriched omega-3 polyunsaturated fatty acids (fish oil) in patients with moderate to severe asthma. Some asthmatics produce a large amount of inflammatory leukotriene proteins-proteins that contribute to wheezing and inflammation in the airway. Inhibiting the detrimental effects of leukotrienes is a key goal of controller therapy in severe asthmatics. Some asthmatic patients appear to have specific mutations of the arachidonate 5-lipoxygenase (ALOX5) gene, one gene that regulates the production of the inflammatory leukotrienes. Omega-3 fatty acids can interfere with the arachidonic acid pathway and decrease the production of leukotrienes, and this may benefit moderate and severe asthma patients. Our hypothesis is that omega-3 fatty acid supplements, added on to a patient's asthma medication regimen, can decrease the number of minor asthma exacerbations compared to patients who do not receive the supplement. Furthermore, we believe that asthma patients with specific ALOX5 gene mutations will benefit most. We will enroll 30 asthma subjects to take part in this trial. They will undergo genotyping of the ALOX5 gene and be treated with omega3-fatty acids (fish oil) and placebo over a nine month period. We expect that this strategy will allow us to discover which moderate and severe asthma patients will benefit most from supplements of omega-3 fatty acids. Treatment of chronic diseases, such as asthma, is a key mission of the Center of Health and Nutrition Research.
Key facts
- Study ID
- NCT00621829
- Run by
- University of California, Davis
- People needed
- 30
- Starts
- 2008-02-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ucdmc/Vanchcs Ccrc — Mather, California, United States
Full record on ClinicalTrials.gov
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