The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma

Asthma Clinical Trial

— VITAS  

Official title:

Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142610
• Other study ID #: P01AT002620-02
• Secondary ID: P01AT002620-02Pr
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2005
• Last updated: March 1, 2013
• Start date: August 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	UNC EPA	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12		measurements have been made alalysis still occuring	No
Secondary	Methacholine reactivity; measured at Weeks 6 and 12		measure finished, analysis continues	No
Secondary	Lung function and symptom scores; measured weekly and at Week 12		measuremet finished, analysis continues	No

External Links

•   Center for Environmental Medicine, Asthma, and Lung Biology