Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
NCT ID: NCT01057615
Last Updated: 2011-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2010-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Fish Oil + Vitamin C Placebo
Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.
Fish Oil
10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks
Ascorbic Acid Placebo
2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
Fish Oil Placebo + Active Vitamin C
Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.
Ascorbic Acid
2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks
Fish Oil Placebo
10 placebo fish oil (soy bean oil) capsules per day for 3 weeks
Active Fish Oil + Active Vitamin C
Following a 2-week washout period, all subjects from the other two arms (n=30) will take 10 active fish oil capsules per day and 2 active vitamin C capsules per day for 3 weeks.
Fish Oil
10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks
Ascorbic Acid
2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks
Interventions
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Fish Oil
10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks
Ascorbic Acid
2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks
Fish Oil Placebo
10 placebo fish oil (soy bean oil) capsules per day for 3 weeks
Ascorbic Acid Placebo
2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of EIB, based on ≥10% fall in post-challenge FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
* Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
* Not currently taking any fish oil or ascorbic acid supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
* Agree to limit fish consumption to 1 fish meal per week throughout the study
* Agree to avoid vitamin C-rich foods throughout the study
Exclusion Criteria
* Pregnancy
* History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
* History of bleeding disorders or delayed clotting time
* History of diabetes
* History of seizures
* Allergy to fish oil or ascorbic acid (vitamin C)
18 Years
40 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Indiana University
Principal Investigators
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Timothy D Mickleborough, PhD
Role: STUDY_DIRECTOR
Indiana University
Locations
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Indiana University
Bloomington, Indiana, United States
Countries
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References
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Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.
Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.
Tecklenburg SL, Mickleborough TD, Fly AD, Bai Y, Stager JM. Ascorbic acid supplementation attenuates exercise-induced bronchoconstriction in patients with asthma. Respir Med. 2007 Aug;101(8):1770-8. doi: 10.1016/j.rmed.2007.02.014. Epub 2007 Apr 5.
Other Identifiers
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0910000751
Identifier Type: -
Identifier Source: org_study_id