Phase 3
N=98
Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Asthma · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01027143 ↗Enrolled (actual)
98
Serious AEs
3.1%
Results posted
Sep 2023
Primary outcome: Primary: Asthma Control Questionnaire (Juniper) — 1.13; 1.08; -0.08; -0.09 score on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- omega-3 polyunsaturated fatty acids (Dietary_supplement); Omega-3 Fatty Acid (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control Questionnaire (Juniper) |
1.13; 1.08; -0.08; -0.09; -0.09; -0.18 | 0.05 |
| SECONDARY N3-to-n6 PUFA Ratio (Granulocytes) |
0.06; 0.10; 0.19; 0.08; 0.17; 0.08 | — |
| SECONDARY N3-to-n6 PUFA Ratio (Monocytes) |
0.04; 0.08; 0.11; 0.05; 0.12; 0.07 | — |
| SECONDARY Asthma Control Test |
19.4; 19.9; 19.5; 20.3; 20.2; 20.4 | — |
| SECONDARY Urinary Leukotriene-E4 |
70.1; 84.0; 78.5; 61.3; 80.6; 66.5 | — |
| SECONDARY FEV1 |
90.2; 90.3; 91.6; 90.2; 91.6; 91.7 | — |
| SECONDARY Exacerbations |
17; 5 | — |
| SECONDARY Phone Contacts |
10; 6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age 12-25
- BMI > 25 (age 18-25) or BMI%>85th (age 12-17) (BMI Liberalized)
- Physician diagnosis of persistent asthma
- Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing
Exclusion Criteria
- pregnancy
- currently taking LTRA for asthma control
- other serious chronic medical condition
- bleeding diathesis
Data sourced from ClinicalTrials.gov (NCT01027143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.