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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fish Oil

Ascorbic Acid

Fish Oil Placebo

Ascorbic Acid Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Ascorbic Acid

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Active Fish Oil + Vitamin C Placebo

Fish Oil Placebo + Active Vitamin C

Active Fish Oil + Active Vitamin C

Arm Description

Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.

Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.

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.

Outcomes

Primary Outcome Measures

Pulmonary Function

Secondary Outcome Measures

Exhaled nitric oxide to measure airway inflammation

Full Information

NCT ID

NCT01057615

First Posted

January 26, 2010

Last Updated

January 28, 2011

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT01057615

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Ascorbic Acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Fish Oil + Vitamin C Placebo

Arm Type

Experimental

Arm Description

Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.

Arm Title

Fish Oil Placebo + Active Vitamin C

Arm Type

Experimental

Arm Description

Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.

Arm Title

Active Fish Oil + Active Vitamin C

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish Oil

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Ascorbic Acid

Other Intervention Name(s)

Vitamin C

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish Oil Placebo

Other Intervention Name(s)

Soy Bean Oil

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Ascorbic Acid Placebo

Other Intervention Name(s)

Table Sugar

Intervention Description

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

Primary Outcome Measure Information:

Title

Pulmonary Function

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Exhaled nitric oxide to measure airway inflammation

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy D Mickleborough, PhD

Organizational Affiliation

Indiana University

Official's Role

Study Director

Facility Information:

Facility Name

Indiana University

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12904324

Citation

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.

Results Reference

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PubMed Identifier

16424411

Citation

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.

Results Reference

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PubMed Identifier

17412579

Citation

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.

Results Reference

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

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