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

• ClinicalTrials.gov Identifier: NCT01057615
• Recruitment Status: Completed
• First Posted: January 27, 2010
• Last Update Posted: January 31, 2011
• Sponsor: Indiana University
• Information provided by: Indiana University

Tracking Information

• First Submitted Date: January 26, 2010
• First Posted Date: January 27, 2010
• Last Update Posted Date: January 31, 2011
• Study Start Date: March 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 26, 2010): Pulmonary Function [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 26, 2010): Exhaled nitric oxide to measure airway inflammation [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• 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
• Dietary Supplement: Fish Oil Placebo
  10 placebo fish oil (soy bean oil) capsules per day for 3 weeks
  Other Name: Soy Bean Oil
• Dietary Supplement: Ascorbic Acid Placebo
  2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
  Other Name: Table Sugar

Study Arms

• 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.
  Interventions:

  • Dietary Supplement: Fish Oil
  • Dietary Supplement: Ascorbic Acid Placebo
• 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.
  Interventions:

  • Dietary Supplement: Ascorbic Acid
  • Dietary Supplement: Fish Oil Placebo
• 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.
  Interventions:

  • Dietary Supplement: Fish Oil
  • Dietary Supplement: Ascorbic Acid

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2011): 14
• Original Estimated Enrollment (submitted: January 26, 2010): 30
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01057615
• Other Study ID Numbers: 0910000751
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Timothy Mickleborough, PhD / Associate Professor, Indiana University
• Original Responsible Party: Same as current
• Current Study Sponsor: Indiana University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Timothy D Mickleborough, PhD; Indiana University

• PRS Account: Indiana University
• Verification Date: January 2011