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Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785460
First Posted: November 5, 2008
Last Update Posted: November 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ruhr University of Bochum
  Purpose
Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the brachial artery.

Condition Intervention Phase
Healthy Subjects Drug: Benfotiamine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Flow mediated dilatation [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Laboratory markers of endothelial function [ Time Frame: 3 days ]

Enrollment: 20
Study Start Date: January 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benfotiamine and Smoking Drug: Benfotiamine
Placebo Comparator: Smoking alone Drug: Benfotiamine

Detailed Description:
Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation (FMD) of the brachial arteryand laboratory parameters (adhesion molecules).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy habitual smokers

Exclusion Criteria:

  • any kind of chronic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785460


Locations
Germany
Heart and Diabetes Center
Bad Oeynhausen, NRW, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Alin Stirban, MD Ruhr-University Bochum
  More Information

Responsible Party: Alin Stirban, Heart and Diabetes Center NRW
ClinicalTrials.gov Identifier: NCT00785460     History of Changes
Other Study ID Numbers: Benfo Smoker
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: November 5, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Benphothiamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action