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

NCT00565214 | Completed

• 1 other identifier: 0705009179
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

vitamin supplements; healthy smokers; epithelial lung tissue; bronchoscopy; antioxidant levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Vitamin supplementation

  After 30 days of intervention

• Oxidant stress in the lung.

  After 30 days of intervention

• Changes in airway epithelial gene expression in genes other than oxidant related genes.

  After 30 days of intervention

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2

PLACEBO COMPARATOR

On Day 1, Group 2 will initiate the placebo in a double-blinded fashion.

Dietary Supplement: Group 2

Interventions

Group 1 DIETARY_SUPPLEMENT

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.

Also known as: Vitamin C, Vitamin E, Selenium

Group 1

Group 2 DIETARY_SUPPLEMENT

The treatment plan involves the administration of a combination of 3 placebos to be taken orally, once daily for a duration of 30 days.

Also known as: Placebo

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ascorbic Acid; Vitamin E; Selenium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: October 1, 2010
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

US (1)