Aortic Valve CalcificationPhase 308-002NCT00785109
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
A Phase 3 study testing Vitamin K supplementation in people with Aortic Valve Calcification, run by RWTH Aachen University at 1 site in Germany.
Trial summary
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Valve Calcification
- What is being tested?
- Vitamin K supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Aug 2015
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aortic valve calcification,verified by echocardiography
Who cannot join
- chronic or acute intestinal diseases
- terminal renal failure
- allergic reaction on soya containing products
- recent additional intake of vitamin K
- oral anticoagulation with vitamin K antagonists (Marcoumar)
- systemic therapy with corticosteroids
Show all 11Show fewer
- anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria
- pregnant or breastfeeding women
- persons without mental ability or capacity to understand and follow the instructions of the investigator
- women of childbearing age without safe contraceptional devices
- minority
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI
Read the detailed description
Patients will be allocated to two groups with either
- additional intake of 2 mg vitamin k1 daily
- controll group without additional intake of Vitamin K
Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.
- Conditions
- Aortic Valve Calcification
- Being tested
- Vitamin K supplementation
- Keywords
- aortic valve calcification, vitamin K supplementation
- Medical subject headings
- Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K supplementationDietary supplement
Daily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 patients daily additional intake of 2mg vitamin k1 Receives: Dietary Supplement: Vitamin K supplementation |
| 2 | Placebo comparator | 100 patients no additional intake of vitamin K Receives: Dietary Supplement: Vitamin K supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
Measured: 18 months
Secondary outcomes (1)
progression of diastolic and systolic dysfunction in the three treatment groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve CalcificationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralf Koos, MD, Principal investigator, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785109
- Sponsor's protocol ID
- Vitamin K Study
- Other IDs
- 2008-005306-39, 2008
- Acronym
- 08-002
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2008
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
- ClinicalTrials.gov ID
- NCT00785109
- Acronym / sponsor ID
- 08-002 / Vitamin K Study
- Conditions
- Aortic Valve Calcification
- Keywords
- aortic valve calcification, vitamin K supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Nov 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.
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI
Detailed description
Patients will be allocated to two groups with either
- additional intake of 2 mg vitamin k1 daily
- controll group without additional intake of Vitamin K
Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Vitamin K supplementation100 patients daily additional intake of 2mg vitamin k1 |
| 2 | Placebo comparator | Dietary Supplement: Vitamin K supplementation100 patients no additional intake of vitamin K |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aortic valve calcification,verified by echocardiography
Key exclusion criteria (11 listed)
- chronic or acute intestinal diseases
- terminal renal failure
- allergic reaction on soya containing products
- recent additional intake of vitamin K
- oral anticoagulation with vitamin K antagonists (Marcoumar)
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 |
|---|---|---|
| Vitamin K supplementationDaily vitamin K supplementation per os (2 mg once a day)Experimental 1 Placebo Experimental 2 | Dietary supplement | 1, 2 |
Primary outcome
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
Time frame: 18 months
1 secondary outcome
progression of diastolic and systolic dysfunction in the three treatment groups
Time frame: 18 months
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 21 Apr 2017.
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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.
Ralf Koos, MD principal investigator
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin K supplementation in people with Aortic Valve Calcification, run by RWTH Aachen University at 1 site in Germany.
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 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 21 Apr 2017. 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 Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K (time frame: 18 months). 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 21 Apr 2017.