Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Phase 3

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Benfotiamine

• Registration Number: NCT00785460
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Status Verified: 2008-11
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Last Update Submitted: 2008-11-04
• Study First Posted: 2008-11-05
• Last Update Posted: 2008-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy habitual smokers

Exclusion Criteria

• any kind of chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smoking alone	Benfotiamine	-
Benfotiamine and Smoking	Benfotiamine	-

Primary Outcome Measures

Name	Time	Method
Flow mediated dilatation	3 days

Secondary Outcome Measures

Name	Time	Method
Laboratory markers of endothelial function	3 days

Trial Locations

Locations (1)

Heart and Diabetes Center; 🇩🇪 Bad Oeynhausen, NRW, Germany