This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.
Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
ProEPA Xtra 1000mg softgels: 3 softgels twice daily
Soybean oil: 3(age 12-25) matched softgel caps twice daily
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Hospital/Dept of Pulmonology
Orlando, Florida, United States
University of South Florida, Morsani College of Medicine
Tampa, Florida, United States
Asthma Control Questionnaire (Juniper)
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
Time frame: baseline, 3 months, 6 months
N3-to-n6 PUFA Ratio (Granulocytes)
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
Time frame: Baseline, 3 and 6 months
N3-to-n6 PUFA Ratio (Monocytes)
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Time frame: Baseline, 3 months, 6 months
Asthma Control Test
The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Time frame: Baseline, 3 months, 6 months
Urinary Leukotriene-E4
Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
Time frame: Baseline, 3 months, 6 months
FEV1
Forced expiratory volume in 1 second is a validated spirometry measure.
Time frame: Baseline, 3 months, 6 months
Exacerbations
Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months
Phone Contacts
Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma
Time frame: 6 months