Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Healthy Subjects Clinical Trial

Official title:

Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785460
• Other study ID #: Benfo Smoker
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2008
• Last updated: November 4, 2008
• Start date: January 2008

Study information

• Verified date: November 2008
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy habitual smokers

Exclusion Criteria:

• any kind of chronic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Benfotiamine

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow mediated dilatation		3 days	No
Secondary	Laboratory markers of endothelial function		3 days	No