The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma
NCT ID: NCT00142610
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2005-08-31
2007-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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vitamin
500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks
Vitamin
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.
Placebo
Vitamin
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.
Interventions
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Vitamin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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David B. Peden, MD
Director Enviro Med Asthma & Lung Biology
Principal Investigators
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David B. Peden, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Center for Environmental Medicine, Asthma, and Lung Biology
Locations
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UNC EPA
Chapel Hill, North Carolina, United States
Countries
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Related Links
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Center for Environmental Medicine, Asthma, and Lung Biology
Other Identifiers
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