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Effect of Folic Acid Treatment in Coronary Artery Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300352
First Posted: March 8, 2006
Last Update Posted: August 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Heart Foundation
Information provided by:
University of Oxford
  Purpose
We seek to examine the effects of folic acid treatment on vascular function in patients with coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular function

Condition Intervention Phase
Coronary Artery Disease Drug: Folic Acid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Folic Acid Treatment in Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Improvement in noninvasive measures of vascular function

Secondary Outcome Measures:
  • Improvement in laboratory measures of vascular function

Estimated Enrollment: 60
Study Start Date: May 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:
Common vascular disease states including diabetes and atherosclerosis are associated with endothelial dysfunction, characterised by reduced bioactivity of nitric oxide (NO). Folates are thought to improve endothelial function,but the mechanism by which this effect occurs is poorly understood. We propose to study the effects of folate supplementation on endothelial function in patients with coronary artery disease.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical diagnosis of coronary artery disease

Exclusion Criteria:

Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300352


Contacts
Contact: Cheerag C Shirodaria, MB BS MRCP +(44)1865-221866 cheerag.shirodaria@cardiov.ox.ac.uk

Locations
United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
British Heart Foundation
Investigators
Principal Investigator: Keith Channon, MD FRCP University of Oxford
  More Information

ClinicalTrials.gov Identifier: NCT00300352     History of Changes
Other Study ID Numbers: 04.OXB.004
First Submitted: March 7, 2006
First Posted: March 8, 2006
Last Update Posted: August 7, 2008
Last Verified: January 2007

Keywords provided by University of Oxford:
Coronary artery disease
Folic acid
Endothelial function

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs