NCT00785460

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
Last Updated

November 5, 2008

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

November 4, 2008

Last Update Submit

November 4, 2008

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilatation

    3 days

Secondary Outcomes (1)

  • Laboratory markers of endothelial function

    3 days

Study Arms (2)

Benfotiamine and Smoking

EXPERIMENTAL
Drug: Benfotiamine

Smoking alone

PLACEBO COMPARATOR
Drug: Benfotiamine

Interventions

BenfotiamineDRUG
Benfotiamine and SmokingSmoking alone

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy habitual smokers

You may not qualify if:

  • any kind of chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Interventions

benphothiamine

Study Officials

  • Alin Stirban, MD

    Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Last Updated

November 5, 2008

Record last verified: 2008-11

Locations

DE(1)