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Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

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ClinicalTrials.gov Identifier: NCT00785460
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
Ruhr University of Bochum

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Drug: Benfotiamine Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers
Study Start Date : January 2008
Primary Completion Date : May 2008

Arm Intervention/treatment
Experimental: Benfotiamine and Smoking Drug: Benfotiamine
Placebo Comparator: Smoking alone Drug: Benfotiamine



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

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


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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

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

Responsible Party: Alin Stirban, Heart and Diabetes Center NRW
ClinicalTrials.gov Identifier: NCT00785460     History of Changes
Other Study ID Numbers: Benfo Smoker
First Posted: November 5, 2008    Key Record Dates
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