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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega-3 fatty acids | Experimental | 3 softgels (EPA, DHA) twice daily |
|
| control | Placebo Comparator | Soybean oil: 3 matched softgel caps twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 polyunsaturated fatty acids | Dietary Supplement | ProEPA Xtra 1000mg softgels: 3 softgels twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| N3-to-n6 PUFA Ratio (Granulocytes) | Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood | Baseline, 3 and 6 months |
| N3-to-n6 PUFA Ratio (Monocytes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason E. Lang, M.D. | Duke Children's Hospital and Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States | ||
| Nemours Children's Hospital/Dept of Pulmonology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30678465 | Derived | Lang JE, Mougey EB, Hossain MJ, Livingston F, Balagopal PB, Langdon S, Lima JJ. Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial. Ann Am Thorac Soc. 2019 May;16(5):554-562. doi: 10.1513/AnnalsATS.201807-446OC. |
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30 were excluded due to medical history and 15 was lost to follow-up during run-in.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Fatty Acids | 3 softgels (EPA, DHA) twice daily omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily |
| FG001 | Control | Soybean oil: 3 matched softgel caps twice daily Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Fatty Acids | 3 softgels (EPA, DHA) twice daily omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily |
| BG001 | Control | Soybean oil: 3 matched softgel caps twice daily Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 3 months, 6 months |
|
Over the course of the study post randomization (24 weeks)
Our adverse event and serious adverse event did not differ from the definitions outlined in clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Fatty Acids | 3 softgels (EPA, DHA) twice daily omega-3 polyunsaturated fatty acids: ProEPA Xtra 1000mg softgels: 3 softgels twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Hospitalized for asthma exacerbation; respiratory distress |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Painful sensation in any part of the head |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Lang, MD | Duke University Medical Center | 919-684-9590 | jason.lang@duke.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Omega-3 Fatty Acid | Drug | Soybean oil: 3(age 12-25) matched softgel caps twice daily |
|
|
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
| 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. | Baseline, 3 months, 6 months |
| Urinary Leukotriene-E4 | Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry. | Baseline, 3 months, 6 months |
| FEV1 | Forced expiratory volume in 1 second is a validated spirometry measure. | 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 | 6 months |
| Phone Contacts | Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma | 6 months |
| Orlando |
| Florida |
| 32827 |
| United States |
| University of South Florida, Morsani College of Medicine | Tampa | Florida | 33612 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Secondary | N3-to-n6 PUFA Ratio (Granulocytes) | Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood | Blood was not successfully drawn in all children | Posted | Mean | 95% Confidence Interval | no units (ratio) | Baseline, 3 and 6 months |
|
|
|
| Secondary | N3-to-n6 PUFA Ratio (Monocytes) | Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood | blood was not successfully drawn in all children | Posted | Mean | 95% Confidence Interval | no units (ratio) | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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. | missing data due to drop outs or staff error | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3 months, 6 months |
|
|
|
| Secondary | Urinary Leukotriene-E4 | Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry. | missing data resulted from participants lost to follow up or not providing urine samples | Posted | Mean | 95% Confidence Interval | pg/mg creatinine | Baseline, 3 months, 6 months |
|
|
|
| Secondary | FEV1 | Forced expiratory volume in 1 second is a validated spirometry measure. | missing data due to participants lost to follow-up or not being able to provide valid spirometry | Posted | Mean | 95% Confidence Interval | percent of predicted | Baseline, 3 months, 6 months |
|
|
|
| Secondary | 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 | all randomized participants | Posted | Number | exacerbations | 6 months |
|
|
|
| Secondary | Phone Contacts | Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma | all randomized participants | Posted | Number | events | 6 months |
|
|
|
| 0 |
| 77 |
| 3 |
| 77 |
| 58 |
| 77 |
| EG001 | Control | Soybean oil: 3 matched softgel caps twice daily Omega-3 Fatty Acid: Soybean oil: 3(age 12-25) matched softgel caps twice daily | 0 | 21 | 0 | 21 | 15 | 21 |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | hematemesis requiring urgent care |
|
|
| Dry Mouth | Immune system disorders | MedDRA (10.0) | Systematic Assessment | Salivary Glands are not making enough saliva in the mouth |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Feeling of queasiness or wooziness or need to vomit |
|
| Bloating | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Intestinal organs are being stretched or distended |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Liquid form of feces discharged from the bowels |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Difficulty emptying the bowels; harden feces |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Accumulation of gas in the stomach |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| URI | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Infection of the upper respiratory system |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Pain and/or inflammation of the throat |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Inflamed cavities around the nasal passages |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
|
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| 3 months |
|
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| 6 months |
|
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| 3 months |
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| 6 months |
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