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

January 26, 2010
January 28, 2011
March 2010
December 2010   (final data collection date for primary outcome measure)
Pulmonary Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057615 on ClinicalTrials.gov Archive Site
Exhaled nitric oxide to measure airway inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2010
December 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057615
0910000751
No
Timothy Mickleborough, PhD / Associate Professor, Indiana University
Indiana University
Not Provided
Study Director: Timothy D Mickleborough, PhD Indiana University
Indiana University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP