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

Asthma Clinical Trial

Official title:

Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057615
• Other study ID #: 0910000751
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2010
• Last updated: January 28, 2011
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Epub 2003 Aug 6. — View 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. Epub 2007 Apr 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function		8 weeks	No
Secondary	Exhaled nitric oxide to measure airway inflammation		8 weeks	No