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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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00693589
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Endothelial Dysfunction
 Drug: folic acid, vitamin B12 and B6 and rosuvastatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Flow mediated dilatation (FMD) [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in biochemistry parameters [ Time Frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Crestor

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693589

Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Kerstin Wustmann, MD Cardiology, Inselspital, University hospital Bern
Study Chair: Yves Allemann, MD Cardiology, Inselspital, University hospital Bern
  More Information

No publications provided

Responsible Party: Allemann, Y., MD, Cardiology, Inselspital Berne
ClinicalTrials.gov Identifier: NCT00693589     History of Changes
Other Study ID Numbers: KEK-Nr. 115/03
Study First Received: June 5, 2008
Last Updated: June 6, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
endothelial function
flow mediated dilatation
rosuvastatin
folic acid
B vitamins

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Folic Acid
Vitamin B Complex
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Hematinics
Vitamins
 Rosuvastatin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013