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Completed

NCT Number: NCT01057615

Effect of Fish Oil and Vitamin C 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fish Oil

Dietary Supplement

10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks

ascorbic acid

Dietary Supplement

2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks

Other names: Vitamin C

Fish oil placebo

Dietary Supplement

10 placebo fish oil (soy bean oil) capsules per day for 3 weeks

Other names: Soy Bean Oil

Ascorbic Acid Placebo

Dietary Supplement

2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks

Other names: Table Sugar

Primary outcomes

  1. Pulmonary Function

    Time frame: 8 weeks

Secondary outcomes

  1. Exhaled nitric oxide to measure airway inflammation

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2010
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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