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

NCT00142610 | Completed Phase 1 DMC

• 3 other identifiers: P01AT002620-02Project #1Grant ID - PO1-AT002620-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

alpha tocopherol; vitamin E; ascorbate; vitamin C; antioxidant; allergic; asthma

Outcome Measures

Primary Outcomes (1)

• Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12

  measurements have been made alalysis still occuring

Secondary Outcomes (2)

• Methacholine reactivity; measured at Weeks 6 and 12

  measure finished, analysis continues

• Lung function and symptom scores; measured weekly and at Week 12

  measuremet finished, analysis continues

Study Arms (2)

vitamin

EXPERIMENTAL

500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks

Dietary Supplement: Vitamin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin

Interventions

Vitamin DIETARY_SUPPLEMENT

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.

Also known as: Vitamin C, Vitamin E

Placebo; vitamin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UNC EPA

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Center for Environmental Medicine, Asthma, and Lung Biology

MeSH Terms

Conditions

Asthma

Interventions

Vitamins; Ascorbic Acid; Vitamin E

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David B. Peden, MD, MS

  Center for Environmental Medicine, Asthma, and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Enviro Med Asthma & Lung Biology

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: August 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 4, 2013

Record last verified: 2013-02

Locations

US (1)