Coronary Artery DiseasePhase 2NCT00300352
Effect of Folic Acid Treatment in Coronary Artery Disease
A Phase 2 study testing Folic Acid in people with Coronary Artery Disease, run by University of Oxford at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Folic Acid
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2004to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coronary artery disease
Who cannot join
- Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX3 9DU
About this study
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
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Folic Acid
- Keywords
- Coronary artery disease, Folic acid, Endothelial function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in noninvasive measures of vascular function
Secondary outcomes (1)
Improvement in laboratory measures of vascular function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startMay 2004
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Investigators
- Keith Channon, MD FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300352
- Sponsor's protocol ID
- 04.OXB.004
- Status last verified
- Jan 2007
- First submitted
- 7 Mar 2006
- Last updated
- 7 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Folic Acid Treatment in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00300352
- Acronym / sponsor ID
- 04.OXB.004
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Folic acid, Endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- May 2004
- Primary completion
- May 2006 (actual)
- First posted
- 8 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of coronary artery disease
Key exclusion criteria (1 listed)
- Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid | Drug | – |
Primary outcome
Improvement in noninvasive measures of vascular function
1 secondary outcome
Improvement in laboratory measures of vascular function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Channon, MD FRCP principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folic Acid in people with Coronary Artery Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheerag C Shirodaria, MB BS MRCP (+(44)1865-221866, cheerag.shirodaria@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in noninvasive measures of vascular function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.