Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers
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|ClinicalTrials.gov Identifier: NCT00565214|
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : May 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Dietary Supplement: Group 1 Dietary Supplement: Group 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||October 2010|
Active Comparator: Group 1
On Day 1, Group 1 will initiate in a double-blinded fashion, a once daily vitamin combination of selenomethionine(400 μg), vitamin E(400 IU), and vitamin C (1000 mg) orally for 30 days at home. After 30 days of treatment with Vitamin supplements, the gene expression of the airway epithelium will be compared to that of the Placebo group.
Dietary Supplement: Group 1
The treatment plan involves the administration of a combination of 3 vitamins (vitamin C 1000 mg, vitamin E 400 IU, selenomethionine 400 μg) to study volunteers in a 2:1 randomization, Vitamins are to be taken orally, once a day, for a duration of 30 days.
Other Name: Vitamin C, Vitamin E, Selenium
Placebo Comparator: Group 2
On Day 1, Group 2 will initiate the placebo in a double-blinded fashion.
Dietary Supplement: Group 2
The treatment plan involves the administration of a combination of 3 placebos to be taken orally, once daily for a duration of 30 days.
Other Name: Placebo
- The effects of the supplements on gene expression [ Time Frame: After 30 days of intervention ]To test whether 1 month of dietary antioxidant vitamin supplements alter the expression in lung epithelial cells of genes related to oxidant response.
- Vitamin supplementation [ Time Frame: After 30 days of intervention ]The ability of vitamin supplementation to raise lung and serum vitamin levels will be evaluated.
- Oxidant stress in the lung. [ Time Frame: After 30 days of intervention ]The levels of oxidant stress in the lung will be evaluated.
- Changes in airway epithelial gene expression in genes other than oxidant related genes. [ Time Frame: After 30 days of intervention ]To determine whether the vitamin supplementation can induce changes in airway epithelial gene expression in genes other than oxidant related genes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565214
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Ronald G Crystal, MD||Weill Medical College of Cornell University|