Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142610
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2005-09-01
Brief Title:
The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAS
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Grant ID - PO1-AT002620-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01AT002620-02 |
| P01AT002620-02 | NIH | None | None |
| Project 1 | None | None | None |