Cardiovascular DiseasePhase 2NCT00693589
Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease
A Phase 2 study testing folic acid, vitamin B12 and B6 and rosuvastatin in people with Cardiovascular Disease and Endothelial Dysfunction, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Endothelial Dysfunction
- What is being tested?
- folic acid, vitamin B12 and B6 and rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Apr 2007
- 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
- CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago
- history of percutaneous coronary intervention (PTCA or stenting)
- confirmed consent
Who cannot join
- myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago
- ongoing treatment with statins
- ongoing vitamin supplementation with folic acid and B vitamins
- <18 years
- active smokers
- uncontrolled arterial hypertension
Show all 11Show fewer
- renal insufficiency
- atrial fibrillation
- liver disease
- NYHA class >2
- familial hypercholesterolemia
About this study
Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.
Read the detailed description
Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.
- Conditions
- Cardiovascular Disease, Endothelial Dysfunction
- Being tested
- folic acid, vitamin B12 and B6 and rosuvastatin
- Keywords
- endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid, vitamin B12 and B6 and rosuvastatinDrug
Also called Crestor
Vitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| R | Active comparator | Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks Receives: Drug: folic acid, vitamin B12 and B6 and rosuvastatin |
| V | Active comparator | Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin Receives: Drug: folic acid, vitamin B12 and B6 and rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilatation (FMD)
Measured: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Secondary outcomes (1)
changes in biochemistry parameters
Measured: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionFeb 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Kerstin Wustmann, MD, Study director, Cardiology, Inselspital, University hospital BernYves Allemann, MD, Study chair, Cardiology, Inselspital, University hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693589
- Sponsor's protocol ID
- KEK-Nr. 115/03
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00693589
- Acronym / sponsor ID
- KEK-Nr. 115/03
- Conditions
- Cardiovascular Disease, Endothelial Dysfunction
- Keywords
- endothelial function, flow mediated dilatation, rosuvastatin, folic acid, B vitamins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 9 Jun 2008 (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.
Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.
Detailed description
Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R | Active comparator | Drug: folic acid, vitamin B12 and B6 and rosuvastatinRosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks |
| V | Active comparator | Drug: folic acid, vitamin B12 and B6 and rosuvastatinVitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago
- history of percutaneous coronary intervention (PTCA or stenting)
- confirmed consent
Key exclusion criteria (11 listed)
- myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago
- ongoing treatment with statins
- ongoing vitamin supplementation with folic acid and B vitamins
- <18 years
- active smokers
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, vitamin B12 and B6 and rosuvastatinAlso: CrestorVitamin supplementation with folic acid 1mg/d, vitamin B12 0.4mg/d and B6 10mg/d po for 6 weeks alone vs. rosuvastatin 10mg/d for 6 weeks alone and thereafter combined treatment for 6 weeks | Drug | R, V |
Primary outcome
Flow mediated dilatation (FMD)
Time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
1 secondary outcome
changes in biochemistry parameters
Time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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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.
Kerstin Wustmann, MD study director
Cardiology, Inselspital, University hospital Bern
Yves Allemann, MD study chair
Cardiology, Inselspital, University hospital Bern
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing folic acid, vitamin B12 and B6 and rosuvastatin in people with Cardiovascular Disease and Endothelial Dysfunction, run by Insel Gruppe AG, University Hospital Bern.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilatation (FMD) (time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment). 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 Nov 2024.