Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

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ClinicalTrials.gov Identifier: NCT01057615

Recruitment Status : Completed

First Posted : January 27, 2010

Last Update Posted : January 31, 2011

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Sponsor:

Information provided by:

Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Dietary Supplement: Fish Oil Dietary Supplement: Ascorbic Acid Dietary Supplement: Fish Oil Placebo Dietary Supplement: Ascorbic Acid Placebo	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Study Start Date :	March 2010
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin C

Drug Information available for: Ascorbic acid Sodium ascorbate Fish oil Magnesium ascorbate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Dietary Supplement: Fish Oil 10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks Dietary Supplement: Ascorbic Acid Placebo 2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks Other Name: Table Sugar
Experimental: 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.	Dietary Supplement: Ascorbic Acid 2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks Other Name: Vitamin C Dietary Supplement: Fish Oil Placebo 10 placebo fish oil (soy bean oil) capsules per day for 3 weeks Other Name: Soy Bean Oil
Experimental: 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.	Dietary Supplement: Fish Oil 10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks Dietary Supplement: Ascorbic Acid 2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks Other Name: Vitamin C

Outcome Measures

Primary Outcome Measures :

Pulmonary Function [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

Exhaled nitric oxide to measure airway inflammation [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057615

Locations

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United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405

Sponsors and Collaborators

Indiana University

Investigators

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Study Director:	Timothy D Mickleborough, PhD	Indiana University

More Information

Publications:

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.

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Responsible Party:	Timothy Mickleborough, PhD / Associate Professor, Indiana University
ClinicalTrials.gov Identifier:	NCT01057615
Other Study ID Numbers:	0910000751
First Posted:	January 27, 2010 Key Record Dates
Last Update Posted:	January 31, 2011
Last Verified:	January 2011

Keywords provided by Indiana University:


Asthma Exercise-Induced Bronchoconstriction Inflammation	Airway Fish Oil Ascorbic Acid

Additional relevant MeSH terms:

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Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity	Immune System Diseases Pathologic Processes Ascorbic Acid Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

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