Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

November 6, 2024 updated by: Insel Gruppe AG, University Hospital Bern
Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago
  • history of percutaneous coronary intervention (PTCA or stenting)
  • confirmed consent

Exclusion Criteria:

  • myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago
  • ongoing treatment with statins
  • ongoing vitamin supplementation with folic acid and B vitamins
  • <18 years
  • active smokers
  • uncontrolled arterial hypertension
  • renal insufficiency
  • atrial fibrillation
  • liver disease
  • NYHA class >2
  • familial hypercholesterolemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R
Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks
Drug: folic acid, vitamin B12 and B6 and rosuvastatin
Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks
Other Names:
  • Crestor
Active Comparator: V
Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin
Drug: folic acid, vitamin B12 and B6 and rosuvastatin
Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flow mediated dilatation (FMD)
Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in biochemistry parameters
Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
after 6 weeks of randomized treatment and after 6 weeks of combined treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Study Director: Kerstin Wustmann, MD, Cardiology, Inselspital, University hospital Bern
  • Study Chair: Yves Allemann, MD, Cardiology, Inselspital, University hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimated)

June 9, 2008

Study Record Updates

Last Update Posted (Actual)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-Nr. 115/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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