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Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids (NOOA)

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ClinicalTrials.gov Identifier: NCT01027143
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Nemours Children's Clinic

Tracking Information
First Submitted Date  ICMJE December 3, 2009
First Posted Date  ICMJE December 7, 2009
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date October 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2009)
Asthma Control Questionnaire (Juniper) [ Time Frame: baseline, 12 weeks, 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01027143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2009)
Asthma symptom exacerbation, plasma membrane PUFA composition, spirometry, peak flow, forced oscillation [ Time Frame: baseline, 12 weeks, 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Official Title  ICMJE Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Brief 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Obesity
Intervention  ICMJE
  • Dietary Supplement: omega-3 polyunsaturated fatty acids
    ProEPA Xtra 1000mg softgels: 3 softgels twice daily
    Other Name: ProEPA Xtra 1000mg softgels
  • Drug: Omega-3 Fatty Acid
    Soybean oil: 3(age 12-25) matched softgel caps twice daily
    Other Name: Placebo Soybean oil 1000mg soft gels
Study Arms  ICMJE
  • Experimental: omega-3 fatty acids
    3 softgels (EPA, DHA) twice daily
    Intervention: Dietary Supplement: omega-3 polyunsaturated fatty acids
  • Placebo Comparator: control
    Soybean oil: 3 matched softgel caps twice daily
    Intervention: Drug: Omega-3 Fatty Acid
Publications * 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 Jan 25. doi: 10.1513/AnnalsATS.201807-446OC. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
144
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2009)
100
Actual Study Completion Date  ICMJE October 22, 2016
Actual Primary Completion Date October 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01027143
Other Study ID Numbers  ICMJE NCCJELK23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)
Investigators  ICMJE
Principal Investigator: Jason E. Lang, M.D. Duke Children's Hospital and Health Center
PRS Account Nemours Children's Clinic
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP