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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014