AsthmaPhase 1NCT01057615
Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
A Phase 1 study testing Fish Oil and Ascorbic Acid in people with Asthma, run by Indiana University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fish Oil and Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Asthma
- Being tested
- Fish Oil, Ascorbic Acid, Fish Oil Placebo, Ascorbic Acid Placebo
- Keywords
- Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Ascorbic Acid
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks
Ascorbic AcidDietary supplement
Also called Vitamin C
2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks
Fish Oil PlaceboDietary supplement
Also called Soy Bean Oil
10 placebo fish oil (soy bean oil) capsules per day for 3 weeks
Ascorbic Acid PlaceboDietary supplement
Also called Table Sugar
2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Fish Oil + Vitamin C Placebo | Experimental | Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks. Receives: Dietary Supplement: Fish Oil; Dietary Supplement: Ascorbic Acid Placebo |
| Fish Oil Placebo + Active Vitamin C | Experimental | Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks. Receives: Dietary Supplement: Ascorbic Acid; Dietary Supplement: Fish Oil Placebo |
| Active Fish Oil + Active Vitamin C | Experimental | 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. Receives: Dietary Supplement: Fish Oil; Dietary Supplement: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
Measured: 8 weeks
Secondary outcomes (1)
Exhaled nitric oxide to measure airway inflammation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Timothy D Mickleborough, PhD, Study director, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057615
- Sponsor's protocol ID
- 0910000751
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2010
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
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 12904324Mickleborough 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 16424411Tecklenburg 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
- ClinicalTrials.gov ID
- NCT01057615
- Acronym / sponsor ID
- 0910000751
- Conditions
- Asthma
- Keywords
- Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Ascorbic Acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Fish Oil + Vitamin C Placebo | Experimental | Dietary Supplement: Fish Oil, Dietary Supplement: Ascorbic Acid PlaceboFifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks. |
| Fish Oil Placebo + Active Vitamin C | Experimental | Dietary Supplement: Ascorbic Acid, Dietary Supplement: Fish Oil PlaceboFifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks. |
| Active Fish Oil + Active Vitamin C | Experimental | Dietary Supplement: Fish Oil, Dietary Supplement: Ascorbic AcidFollowing 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish Oil10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks | Dietary supplement | Active Fish Oil + Active Vitamin C, Active Fish Oil + Vitamin C Placebo |
| Ascorbic AcidAlso: Vitamin C2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks | Dietary supplement | Active Fish Oil + Active Vitamin C, Fish Oil Placebo + Active Vitamin C |
| Fish Oil PlaceboAlso: Soy Bean Oil10 placebo fish oil (soy bean oil) capsules per day for 3 weeks | Dietary supplement | Fish Oil Placebo + Active Vitamin C |
| Ascorbic Acid PlaceboAlso: Table Sugar2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks | Dietary supplement | Active Fish Oil + Vitamin C Placebo |
Primary outcome
Pulmonary Function
Time frame: 8 weeks
1 secondary outcome
Exhaled nitric oxide to measure airway inflammation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
- Background: PubMed 12904324Mickleborough 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.
- Background: PubMed 16424411Mickleborough 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.
- Background: PubMed 17412579Tecklenburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy D Mickleborough, PhD study director
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fish Oil and Ascorbic Acid in people with Asthma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057615, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.