Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, University of Connecticut
ClinicalTrials.gov Identifier:
NCT01314443
First received: March 10, 2011
Last updated: January 3, 2014
Last verified: January 2014
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Endothelial Dysfunction
Interventions: Other: Nicotine Replacement Therapy (NRT)
Dietary Supplement: Gamma-Tocopherol
Other: Placebo
Behavioral: Smoking cessation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place in and around the community surrounding the University of Connecticut. Recruitment occurred from 2010-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Health status of participants was determined from a comprehensive metabolic panel as well as circulating lipid levels. Individuals having serum chemistries outside of acceptable limits were not enrolled.

Reporting Groups
  Description
Dietary Supplement + Smoking Cessation Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
Placebo + Smoking Cessation Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
Dietary Supplement + Nicotine Replacement Therapy Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Placebo + Nicotine Replacement Therapy Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy

Participant Flow:   Overall Study
    Dietary Supplement + Smoking Cessation     Placebo + Smoking Cessation     Dietary Supplement + Nicotine Replacement Therapy     Placebo + Nicotine Replacement Therapy  
STARTED     18     19     15     15  
COMPLETED     14     16     13     13  
NOT COMPLETED     4     3     2     2  
Withdrawal by Subject                 2                 1                 1                 1  
Protocol Violation                 2                 2                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
11 participants from the 67 participants enrolled in the study were excluded from all analysis (including baseline). Five participants withdrew from the study before completion and six participants were identified as non-compliant and were removed from the study. Thus, baseline analysis was performed on the remaining 56 participants.

Reporting Groups
  Description
Supplement + Smoking Cessation Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
Placebo + Smoking Cessation Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
Supplement + Nicotine Replacement Therapy Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
Placebo + Nicotine Replacement Therapy Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
Total Total of all reporting groups

Baseline Measures
    Supplement + Smoking Cessation     Placebo + Smoking Cessation     Supplement + Nicotine Replacement Therapy     Placebo + Nicotine Replacement Therapy     Total  
Number of Participants  
[units: participants]
  14     16     13     13     56  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     14     16     13     13     56  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  22  ± 4     22  ± 4     26  ± 8     25  ± 8     24  ± 6  
Gender  
[units: participants]
         
Female     5     5     5     4     19  
Male     9     11     8     9     37  
Region of Enrollment  
[units: participants]
         
United States     14     16     13     13     56  



  Outcome Measures
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1.  Primary:   Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0   [ Time Frame: Day 0 and 7 of intervention ]

2.  Secondary:   Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.   [ Time Frame: Day 0 and 7 of intervention ]

3.  Secondary:   Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.   [ Time Frame: Day 0 and 7 of intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Very few women were enrolled thereby precluding any assessment of potential gender differences for our outcome variables.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard Bruno, PhD, RD
Organization: Ohio State University
phone: 614-292-5522
e-mail: bruno.27@osu.edu


Publications of Results:

Responsible Party: Richard Bruno, University of Connecticut
ClinicalTrials.gov Identifier: NCT01314443     History of Changes
Other Study ID Numbers: H10-212
Study First Received: March 10, 2011
Results First Received: December 12, 2012
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board