Status:
COMPLETED
The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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, muc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00142610
Start Date
August 1 2005
End Date
December 1 2007
Last Update
March 4 2013
Active Locations (1)
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1
UNC EPA
Chapel Hill, North Carolina, United States, 27599