NCT01027143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2016

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

September 8, 2023

Completed
Last Updated

September 8, 2023

Status Verified

March 1, 2016

Enrollment Period

6.3 years

First QC Date

December 3, 2009

Results QC Date

June 27, 2023

Last Update Submit

August 15, 2023

Conditions

AsthmaObesity

Keywords

AsthmaObesityPharmacogeneticsNutrigenetics

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • N3-to-n6 PUFA Ratio (Granulocytes)

    Baseline, 3 and 6 months

  • N3-to-n6 PUFA Ratio (Monocytes)

    Baseline, 3 months, 6 months

  • Asthma Control Test

    Baseline, 3 months, 6 months

  • Urinary Leukotriene-E4

    Baseline, 3 months, 6 months

  • FEV1

    Baseline, 3 months, 6 months

  • +2 more secondary outcomes

Study Arms (2)

omega-3 fatty acids

EXPERIMENTAL

3 softgels (EPA, DHA) twice daily

Dietary Supplement: omega-3 polyunsaturated fatty acids

control

PLACEBO COMPARATOR

Soybean oil: 3 matched softgel caps twice daily

Drug: Omega-3 Fatty Acid

Interventions

omega-3 polyunsaturated fatty acidsDIETARY_SUPPLEMENT

ProEPA Xtra 1000mg softgels: 3 softgels twice daily

Also known as: ProEPA Xtra 1000mg softgels
omega-3 fatty acids
Omega-3 Fatty AcidDRUG

Soybean oil: 3(age 12-25) matched softgel caps twice daily

Also known as: Placebo Soybean oil 1000mg soft gels
control

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • currently taking LTRA for asthma control
  • other serious chronic medical condition
  • bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital/Dept of Pulmonology

Orlando, Florida, 32827, United States

Location

University of South Florida, Morsani College of Medicine

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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.

    PMID: 30678465DERIVED

MeSH Terms

Conditions

AsthmaObesity

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Results Point of Contact

Title
Jason Lang, MD
Organization
Duke University Medical Center
jason.lang@duke.edu
919-684-9590

Study Officials

  • Jason E. Lang, M.D.

    Duke Children's Hospital and Health Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 7, 2009

Study Start

July 1, 2010

Primary Completion

October 22, 2016

Study Completion

October 22, 2016

Last Updated

September 8, 2023

Results First Posted

September 8, 2023

Record last verified: 2016-03

Locations

US(3)