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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: Completed NA study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Weill Medical College of Cornell University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To test whether 1 month of dietary antioxidant vitamin supplements alter the expression in lung epithelial cells of genes related to oxidant response.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Group 1
- DIETARY_SUPPLEMENT Group 2
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-10 |
| Phase | NA |
What the finished NCT00565214 record still lists
NCT00565214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 650-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00565214's enrollment target sits among peer trials
46 33rd of 36 higher than 4 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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