Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers
Verified date | May 2017 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | October 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effects of the supplements on gene expression | To test whether 1 month of dietary antioxidant vitamin supplements alter the expression in lung epithelial cells of genes related to oxidant response. | After 30 days of intervention | |
Secondary | Vitamin supplementation | The ability of vitamin supplementation to raise lung and serum vitamin levels will be evaluated. | After 30 days of intervention | |
Secondary | Oxidant stress in the lung. | The levels of oxidant stress in the lung will be evaluated. | After 30 days of intervention | |
Secondary | Changes in airway epithelial gene expression in genes other than oxidant related genes. | To determine whether the vitamin supplementation can induce changes in airway epithelial gene expression in genes other than oxidant related genes. | After 30 days of intervention |
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