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NCT00565214 · ClinicalTrials.gov registry record · NA

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

A NA study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Weill Medical College of Cornell University.

Completed
Registry status
NA
Development phase
46
Enrollment target
1
Study location

NCT00565214 is a NA study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 46 participants, below the 650-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00565214, a NA study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
NA
Development phase
46 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DIETARY_SUPPLEMENT Group 1
  • DIETARY_SUPPLEMENT Group 2

Study Locations (1)

New York

  • Weill Cornell Medical College - New York

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2007-09
Est. Completion 2010-10
Phase NA

What the Registry Record Tells You About NCT00565214

The ClinicalTrials.gov registry entry for NCT00565214 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 650-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (93% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 2 interventions - of which Group 1 is the first listed.

NCT00565214 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00565214 about?

NCT00565214 is a clinical study titled "Effect of Supplementary Vitamins on Oxidant Gene Expression in the Lungs of Healthy Smokers". 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 pro...

What is the current status of trial NCT00565214?

This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2007-09. Estimated completion is 2010-10.

What conditions does trial NCT00565214 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).

What interventions are being tested in trial NCT00565214?

The interventions under investigation include: Group 1 (DIETARY_SUPPLEMENT), Group 2 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00565214?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00565214 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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