Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

Smoking damages the airway epithelium. The major mechanism by which this is done is by molecules called free radicals. Our body attempts to deal with these damaging molecules in two ways. One mechanism is via the presence of protective anti-oxidant vitamins and the other is via proteins that are produced by the body to convert free radicals to safer, less reactive molecules. Vitamins in our diet play a significant role in antioxidant defenses by directly neutralizing the damaging free-radicals and by providing co-factors to cellular proteins that neutralize the free radicals. This project is designed to look at the effects of giving individuals supplemental vitamins to see if it improves their defenses against oxidant insults. The investigators plan to look at the effects of these supplements over a 30 day period and monitor the effects by measuring vitamin levels in the blood and in the lung, and by measuring the response of cells in the lung through the increase or decrease in expression of genes responsive to oxidants. To participate in this protocol, the research subject should first be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", fulfilling the inclusion/exclusion criteria of that protocol. They will be invited to participate in this Vitamin protocol only if they meet the additional inclusion/exclusion criteria of this protocol.

Key facts

Study ID

NCT00565214

Run by

Weill Medical College of Cornell University

People needed

46

Starts

2007-09-01

Expected to finish

2010-10-01

Last updated by the study team

2017-05-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy."
• All study subjects should be able to provide informed consent.
• Males or females ages 18 years and older.
• Current smokers with at least a 15 pack-year history (1 pack year = on average 20 cigarettes per day for 1 year).

You may not qualify if…

• Drug and/or alcohol abuse within the past six months.
• Individuals already on supplemental vitamins.
• Subjects intending to quit smoking in the next 30 days.

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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