Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00785460
First received: November 4, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Flow mediated dilatation [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory markers of endothelial function [ Time Frame: 3 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy habitual smokers

Exclusion Criteria:

  • any kind of chronic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alin Stirban, Heart and Diabetes Center NRW
ClinicalTrials.gov Identifier: NCT00785460     History of Changes
Other Study ID Numbers: Benfo Smoker
Study First Received: November 4, 2008
Last Updated: November 4, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Benphothiamine
Thiamine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014