Condition category
Circulatory System
Date applied
06/03/2006
Date assigned
06/03/2006
Last edited
07/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Channon

ORCID ID

Contact details

Department of Cardiovascular Medicine
University of Oxford
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

Acronym

Study hypothesis

Folic acid improves vascular function in patients with coronary artery disease

Ethics approval

The study has been approved by the Oxford Local Research Ethics Committee (Ref no. 04.OXB.004)

Study design

Placebo-controlled randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary artery disease

Intervention

Folic acid versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Folic acid

Primary outcome measures

Improvement in Magnetic Resonance (MR) measures of vascular function

Secondary outcome measures

Improvement in laboratory measures of vascular function

Overall trial start date

01/05/2004

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with coronary artery disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Metallic implants or contraindications to Magnetic Resonance Imaging (MRI)
2. Severe renal or hepatic dysfunction
3. Recent acute coronary event

Recruitment start date

01/05/2004

Recruitment end date

30/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiovascular Medicine
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF JRF No: FS/03/105/16340)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17420345

Publication citations

  1. Results

    Shirodaria C, Antoniades C, Lee J, Jackson CE, Robson MD, Francis JM, Moat SJ, Ratnatunga C, Pillai R, Refsum H, Neubauer S, Channon KM, Global improvement of vascular function and redox state with low-dose folic acid: implications for folate therapy in patients with coronary artery disease., Circulation, 2007, 115, 17, 2262-2270, doi: 10.1161/CIRCULATIONAHA.106.679084.

Additional files

Editorial Notes