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Effect of Folic Acid Treatment in Coronary Artery Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00300352
First received: March 7, 2006
Last updated: August 6, 2008
Last verified: January 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Folic Acid Treatment in Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00300352     History of Changes
Other Study ID Numbers: 04.OXB.004
Study First Received: March 7, 2006
Last Updated: August 6, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013