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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00142610 |
This study will determine if airway antioxidant levels in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Condition | Intervention | Phase |
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Asthma |
Dietary Supplement: Vitamin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics |
Estimated Enrollment: | 40 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
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vitamin: Experimental
500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks
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Dietary Supplement: 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.
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Placebo: Placebo Comparator |
Dietary Supplement: 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.
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
UNC EPA | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | David B. Peden, MD, MS | Center for Environmental Medicine, Asthma, and Lung Biology |
Responsible Party: | University of North Carolina ( David B. Peden MD ) |
Study ID Numbers: | P01 AT002620-02, Project #1, Grant ID - PO1-AT002620-02 |
Study First Received: | September 1, 2005 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00142610 |
Health Authority: | United States: Federal Government |
alpha tocopherol vitamin E ascorbate vitamin C |
antioxidant allergic asthma |
Tocopherols Tocopherol acetate Vitamin E Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Ascorbic Acid Alpha-Tocopherol Respiratory Hypersensitivity |
Antioxidants Molecular Mechanisms of Pharmacological Action Immune System Diseases Bronchial Diseases Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |