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NCT00300352 Clinical Trial

Effect of Folic Acid Treatment in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:
Effect of Folic Acid Treatment in Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00300352
Other study ID # 04.OXB.004
Secondary ID
Status Recruiting
Phase Phase 2
First received March 7, 2006
Last updated August 6, 2008
Start date May 2004

Study information
Verified date January 2007
Source University of Oxford
Contact Cheerag C Shirodaria, MB BS MRCP
Phone +(44)1865-221866
Email cheerag.shirodaria@cardiov.ox.ac.uk
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Clinical diagnosis of coronary artery disease

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Folic Acid

Locations
Country Name City State
United Kingdom University of Oxford Oxford

Sponsors (2)
Lead Sponsor Collaborator
University of Oxford British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in noninvasive measures of vascular function
Secondary Improvement in laboratory measures of vascular function
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