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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00142610
First received: September 1, 2005
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

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
Asthma
Dietary Supplement: Vitamin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12 [ Time Frame: measurements have been made alalysis still occuring ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Methacholine reactivity; measured at Weeks 6 and 12 [ Time Frame: measure finished, analysis continues ] [ Designated as safety issue: No ]
  • Lung function and symptom scores; measured weekly and at Week 12 [ Time Frame: measuremet finished, analysis continues ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin
500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks
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.
Other Names:
  • Vitamin C
  • Vitamin E
Placebo Comparator: Placebo 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.
Other Names:
  • Vitamin C
  • Vitamin E

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142610

Locations
United States, North Carolina
UNC EPA
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David B. Peden, MD, MS Center for Environmental Medicine, Asthma, and Lung Biology
  More Information

Additional Information:
No publications provided

Responsible Party: David B. Peden, MD, Director Enviro Med Asthma & Lung Biology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00142610     History of Changes
Other Study ID Numbers: P01 AT002620-02, P01AT002620-02, Project #1, Grant ID - PO1-AT002620-02
Study First Received: September 1, 2005
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
alpha tocopherol
vitamin E
ascorbate
vitamin C
antioxidant
allergic
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 16, 2014