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Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

NCT ID: NCT00785460

Last Updated: 2008-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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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

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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).

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Study Groups

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Benfotiamine and Smoking

Group Type EXPERIMENTAL

Benfotiamine

Intervention Type DRUG

Smoking alone

Group Type PLACEBO_COMPARATOR

Benfotiamine

Intervention Type DRUG

Interventions

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Benfotiamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy habitual smokers

Exclusion Criteria

* any kind of chronic disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Heart and Diabetes Center NRW

Principal Investigators

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Alin Stirban, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr-University Bochum

Locations

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Heart and Diabetes Center

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Benfo Smoker

Identifier Type: -

Identifier Source: org_study_id