Clinical trial NCT01057615: Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Official title: Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Exercise-Induced Bronchoconstriction
Inflammation
Airway
Fish Oil
Ascorbic Acid
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.

Detailed description: The aim of this study is to extend previous findings that nutritional supplementation or dietary modification can ameliorate exercise-induced bronchoconstriction. It has been shown in separate studies that fish oil and ascorbic acid (vitamin C) individually protect against EIB by improving pulmonary function and reducing airway inflammation. The main aim of this study is to determine the comparative and additive effects of fish oil and ascorbic acid supplementation on EIB and airway inflammation in asthmatic individuals.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
* 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:

* Resting FEV1 (the amount of air blown out in the first second of a forced exhalation) \<60% of predicted when off medication
* 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)

Primary outcomes:
measure: Pulmonary Function
timeFrame: 8 weeks
Secondary outcomes:
measure: Exhaled nitric oxide to measure airway inflammation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Timothy D Mickleborough, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.