AsthmaPhase 1VITASNCT00142610
The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma
A Phase 1 study testing Vitamin in people with Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study will determine if airway antioxidant levels in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Vitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2007
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; tree mix; grass mix; weed mix; mold mix 1; mold mix 2; rat; mouse; guinea pig; rabbit; cat; or dog
- Oxygen saturation greater than 94% at baseline
- Systolic blood pressure between 150 and 90 mm Hg, diastolic blood pressure between 90 and 60 mm Hg
- Physician-diagnosed asthma or history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma
- Airway reactivity as determined by either a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used or 12% reversibility of baseline lung function with albuterol therapy for two of the three measures: FVC, FEV1, and FEF25-75%
- Agree to discontinue use of vitamin supplements for the duration of the study
- On a stable regimen of maintenance asthma therapy that has not changed within the month prior to participation
Who cannot join
- Chronic medical condition that may make vitamin E and vitamin C treatment medically inadvisable (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- History of kidney stones
- Use of anticoagulants (e.g., warfarin, heparin, or clopindogrel)
- Pregnant or breastfeeding
- Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirkulast) for at least one month is not criteria for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics
This study will determine if airway antioxidant levels in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Read the detailed description
Eosinophils and neutrophils are inflammatory cells located in the airways and lungs. When they are activated, they generate oxidants, which irritates the mucosal cells in the airways. As a result, mucus develops in the lungs. Allergens can activate the inflammatory cells, thereby worsening the symptoms of asthma in allergic asthmatics. Vitamins E (alpha-tocopherol) and C (ascorbate) have been shown to decrease asthma exacerbation associated with exposure to ozone. Enhancing antioxidant and anti-inflammatory defenses in the airways and lungs is a promising approach for treating respiratory diseases aggravated by allergies. This study will determine if airway antioxidants in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Participants in this double-blind study will be randomly assigned to receive either a combination of alpha-tocopherol and ascorbate or placebo. Treatments will be administered daily for 12 weeks. Baseline assessments will measure airway and circulating antioxidant levels, inflammatory cells, lung function, respiratory symptoms, and methacholine reactivity. Allergy skin tests will also be performed to determine the state of atopy, which is a hereditary predisposition toward developing certain hypersensitivity reactions. Following baseline assessments, lung assessments will be conducted weekly for 12 weeks, sputum and blood samples will be collected bi-weekly, and methacholine reactivity will be assessed at Weeks 6 and 12.
- Conditions
- Asthma
- Being tested
- Vitamin
- Keywords
- alpha tocopherol, vitamin E, ascorbate, vitamin C, antioxidant, allergic, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaminDietary supplement
Also called Vitamin C, Vitamin E
This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
| Study group | Role | What they receive |
|---|---|---|
| vitamin | Experimental | 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks Receives: Dietary Supplement: Vitamin |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12
Measured: measurements have been made alalysis still occuring
Secondary outcomes (2)
Methacholine reactivity; measured at Weeks 6 and 12
Measured: measure finished, analysis continues
Lung function and symptom scores; measured weekly and at Week 12
Measured: measuremet finished, analysis continues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, David B. Peden, MD, University of North Carolina, Chapel Hill
- Investigators
- David B. Peden, MD, MS, Principal investigator, Center for Environmental Medicine, Asthma, and Lung Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142610
- Sponsor's protocol ID
- P01AT002620-02
- Other IDs
- P01AT002620-02, Project #1, Grant ID - PO1-AT002620-02
- Acronym
- VITAS
- Status last verified
- Feb 2013
- First submitted
- 1 Sep 2005
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics
- ClinicalTrials.gov ID
- NCT00142610
- Acronym / sponsor ID
- VITAS / P01AT002620-02
- Conditions
- Asthma
- Keywords
- alpha tocopherol, vitamin E, ascorbate, vitamin C, antioxidant, allergic, asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Sep 2005 (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.
This study will determine if airway antioxidant levels in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Detailed description
Eosinophils and neutrophils are inflammatory cells located in the airways and lungs. When they are activated, they generate oxidants, which irritates the mucosal cells in the airways. As a result, mucus develops in the lungs. Allergens can activate the inflammatory cells, thereby worsening the symptoms of asthma in allergic asthmatics. Vitamins E (alpha-tocopherol) and C (ascorbate) have been shown to decrease asthma exacerbation associated with exposure to ozone. Enhancing antioxidant and anti-inflammatory defenses in the airways and lungs is a promising approach for treating respiratory diseases aggravated by allergies. This study will determine if airway antioxidants in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Participants in this double-blind study will be randomly assigned to receive either a combination of alpha-tocopherol and ascorbate or placebo. Treatments will be administered daily for 12 weeks. Baseline assessments will measure airway and circulating antioxidant levels, inflammatory cells, lung function, respiratory symptoms, and methacholine reactivity. Allergy skin tests will also be performed to determine the state of atopy, which is a hereditary predisposition toward developing certain hypersensitivity reactions. Following baseline assessments, lung assessments will be conducted weekly for 12 weeks, sputum and blood samples will be collected bi-weekly, and methacholine reactivity will be assessed at Weeks 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin | Experimental | Dietary Supplement: Vitamin500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; tree mix; grass mix; weed mix; mold mix 1; mold mix 2; rat; mouse; guinea pig; rabbit; cat; or dog
- Oxygen saturation greater than 94% at baseline
- Systolic blood pressure between 150 and 90 mm Hg, diastolic blood pressure between 90 and 60 mm Hg
- Physician-diagnosed asthma or history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma
- Airway reactivity as determined by either a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used or 12% reversibility of baseline lung function with albuterol therapy for two of the three measures: FVC, FEV1, and FEF25-75%
Key exclusion criteria (5 listed)
- Chronic medical condition that may make vitamin E and vitamin C treatment medically inadvisable (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- History of kidney stones
- Use of anticoagulants (e.g., warfarin, heparin, or clopindogrel)
- Pregnant or breastfeeding
- Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirkulast) for at least one month is not criteria for exclusion.
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 |
|---|---|---|
| VitaminAlso: Vitamin C, Vitamin EThis is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics. | Dietary supplement | Placebo, vitamin |
Primary outcome
Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12
Time frame: measurements have been made alalysis still occuring
2 secondary outcomes
Methacholine reactivity; measured at Weeks 6 and 12
Time frame: measure finished, analysis continues
Lung function and symptom scores; measured weekly and at Week 12
Time frame: measuremet finished, analysis continues
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 4 Mar 2013.
- Center for Environmental Medicine, Asthma, and Lung BiologyLink provided by the sponsor.
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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.
David B. Peden, MD, MS principal investigator
Center for Environmental Medicine, Asthma, and Lung Biology
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 Vitamin in people with Asthma, run by University of North Carolina, Chapel Hill 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 7 inclusion and 5 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 4 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12 (time frame: measurements have been made alalysis still occuring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2013.