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CompletedNCT01057615Updated Jan 31, 2011

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

A Phase 1 interventional study of Fish Oil and Ascorbic Acid in Asthma, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2011-01-31.

Sponsored by Indiana University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Asthma

Keywords

  • Asthma
  • Exercise-Induced Bronchoconstriction
  • Inflammation
  • Airway
  • Fish Oil
  • Ascorbic Acid
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 14 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

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.

    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.

    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.

    Dietary Supplement: Fish Oil · Dietary Supplement: Ascorbic Acid

Interventions

  • Dietary supplementFish Oil

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

  • Dietary supplementAscorbic Acid

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

    Also known as: Vitamin C

  • Dietary supplementFish Oil Placebo

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

    Also known as: Soy Bean Oil

  • Dietary supplementAscorbic Acid Placebo

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

    Also known as: Table Sugar

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What researchers measure

Primary outcomes

  1. Pulmonary Function

    Time frame: 8 weeks

Secondary outcomes

  1. Exhaled nitric oxide to measure airway inflammation

    Time frame: 8 weeks

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Study locations

1 site
  • Indiana University
    Bloomington, Indiana 47405, United States
08

References and documents

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. PubMed 12904324 ↗
  • 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. PubMed 16424411 ↗
  • 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. PubMed 17412579 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01057615
Lead sponsor
Indiana University
First posted
Jan 27, 2010
Start date
Mar 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jan 31, 2011

Study contacts

Timothy D Mickleborough, PhD
study director · Indiana University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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