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NCT01314443 · ClinicalTrials.gov registry record · Phase 1
Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function
A Phase 1 study, sponsored by University of Connecticut.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT01314443 is a Phase 1 study that has completed, run by University of Connecticut. The registered enrollment target is 67 participants.
The verdict
NCT01314443, a Phase 1 study, has completed, sponsored by University of Connecticut.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the leading cause of premature mortality in the US. The detrimental effects of smoking on vascular dysfunction are attributed to the effects of smoke itself and the inflammatory responses it induces. Smoking cessation restores vascular function by alleviating these stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the prevailing approach to mitigate tobacco dependence, fails to allow full restoration of vascular function. Thus, a critical public health problem exists to understand how NRT prevents restoration of vascular function and how these NRT-mediated impairments can be overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining how smoking cessation and g-T restore vascular function. The hypothesis is that smoking cessation and dietary g-T supplementation will synergistically restore smoking-induced impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T administration, vascular function will be evaluated using a non-invasive ultrasound technique and an array of antioxidants and biomarkers for vascular inflammation and oxidative/nitrosative stress responses will be assessed. Collectively, these studies will help identify how vascular function is regulated in individuals undergoing smoking cessation, and whether g-T can be used as a strategy to better improve vascular function during smoking cessation.
Interventions
- OTHER Placebo
- BEHAVIORAL Smoking cessation
- OTHER Nicotine Replacement Therapy (NRT)
- DIETARY_SUPPLEMENT Gamma-Tocopherol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01314443
The ClinicalTrials.gov registry entry for NCT01314443 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Connecticut, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01314443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01314443 about?
NCT01314443 is a clinical study titled "Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function". Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the leading cause of premature mortality in the US. The detrimental effects of smoking on vascular dysfunction are attributed to the effects of smoke itself and the inflammatory responses it induces. Smoking cessa...
What is the current status of trial NCT01314443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2011-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01314443?
The interventions under investigation include: Placebo (OTHER), Smoking cessation (BEHAVIORAL), Nicotine Replacement Therapy (NRT) (OTHER), Gamma-Tocopherol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01314443?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
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