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

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01057615
First received: January 26, 2010
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Asthma
Dietary Supplement: Fish Oil
Dietary Supplement: Ascorbic Acid
Dietary Supplement: Fish Oil Placebo
Dietary Supplement: Ascorbic Acid Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pulmonary Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled nitric oxide to measure airway inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057615

Locations
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
Investigators
Study Director: Timothy D Mickleborough, PhD Indiana University
  More Information

Publications:
Responsible Party: Timothy Mickleborough, PhD / Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01057615     History of Changes
Other Study ID Numbers: 0910000751
Study First Received: January 26, 2010
Last Updated: January 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Asthma
Exercise-Induced Bronchoconstriction
Inflammation
Airway
Fish Oil
Ascorbic Acid

Additional relevant MeSH terms:
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014