ThrombosisPhase 2SAFEKNCT01533441
Vitamin K2 Intervention in Patients With Vitamin K Antagonists
A Phase 2 study testing Vitamin K2 in people with Thrombosis, run by Danisco at 1 site in France.
Trial summary
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- Vitamin K2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Apr 2013
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- treated with anticoagulants
- INR range between 2-3
- TTR (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion
Who cannot join
- consumption of significant amounts of products conatining vitamin K
- regular consumption of dietary supplements susceptible to contain vitamin K
- milk intolerant or refusing a daily consumption of dairy product
- previous insufficient earlier therapeutic VKA follow-up
- cardiac, renal or severe respiratory insufficiency, diseases interfering fat absorption, significant abnormalities in safety parameters, clinically significant thrombotic or hemorrhagic event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.
Read the detailed description
Randomisation of the study subjects will be done by two randomisation lists depending on whether the dose of VKA is high or low. Randomisation will be balanced and stratified depending on the average dose of VKA before the inclusion in order that each arm would have the same number of patients receiving a dose lower than the used anticoagulant treatments.
The level of vitamin K intake will be determined during the study visits using dietary questionnaire.
- Conditions
- Thrombosis
- Being tested
- Vitamin K2
- Keywords
- anticoagulant therapy, INR, vitamin K2, vitamin K antagonist
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
Also called phylloquinone,, menaquinone
4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
| Study group | Role | What they receive |
|---|---|---|
| placebo low VKA | Placebo comparator | Not described Receives: Dietary Supplement: Vitamin K2 |
| Placebo high VKA | Placebo comparator | Microcrystalline cellulose Receives: Dietary Supplement: Vitamin K2 |
| Vitamin K2 Low VKA | Active comparator | Not described Receives: Dietary Supplement: Vitamin K2 |
| Vitamin K2 high VKA | Active comparator | Not described Receives: Dietary Supplement: Vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
INR
Prothrombin time
Measured: change from baseline at two months
INR
prothrombin time
Measured: change from baseline at four months
Secondary outcomes (8)
c/uc osteocalcin ratio
immunoassay method
Measured: change from baseline at two months
FVII from plasma
chronometric method
Measured: change from baseline at two months
FII
chronometric method
Measured: change from baseline at two months
Plasma vitamin K levels
HPLC
Measured: change from base-line at two months
c/uc osteocalcin ratio
immunoassay method
Measured: change from baseline at four months
FVII
chronometric method
Measured: change from baseline at four months
FII
chronometric method
Measured: change from baseline at four months
Plasma vitamin K level
HPLC
Measured: change from baseline at four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsti Tiihonen, PhD, Study director, Danisco Sweeteners OyLudovic Drouet, Professor, Study chair, IVS/CREATIF, Hopital LariboisiereClaire Bal dit Sollier, Study chair, IVS/CREATIF, Hopital Lariboisiere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533441
- Sponsor's protocol ID
- SAFE K study
- Acronym
- SAFEK
- Status last verified
- Apr 2014
- First submitted
- 3 Feb 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)
- ClinicalTrials.gov ID
- NCT01533441
- Acronym / sponsor ID
- SAFEK / SAFE K study
- Conditions
- Thrombosis
- Keywords
- anticoagulant therapy, INR, vitamin K2, vitamin K antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Feb 2012 (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.
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.
Detailed description
Randomisation of the study subjects will be done by two randomisation lists depending on whether the dose of VKA is high or low. Randomisation will be balanced and stratified depending on the average dose of VKA before the inclusion in order that each arm would have the same number of patients receiving a dose lower than the used anticoagulant treatments.
The level of vitamin K intake will be determined during the study visits using dietary questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo low VKA | Placebo comparator | Dietary Supplement: Vitamin K2 |
| Placebo high VKA | Placebo comparator | Dietary Supplement: Vitamin K2Microcrystalline cellulose |
| Vitamin K2 Low VKA | Active comparator | Dietary Supplement: Vitamin K2 |
| Vitamin K2 high VKA | Active comparator | Dietary Supplement: Vitamin K2 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- treated with anticoagulants
- INR range between 2-3
- TTR (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion
Key exclusion criteria (5 listed)
- consumption of significant amounts of products conatining vitamin K
- regular consumption of dietary supplements susceptible to contain vitamin K
- milk intolerant or refusing a daily consumption of dairy product
- previous insufficient earlier therapeutic VKA follow-up
- cardiac, renal or severe respiratory insufficiency, diseases interfering fat absorption, significant abnormalities in safety parameters, clinically significant thrombotic or hemorrhagic event
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 K2Also: phylloquinone,, menaquinone4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention | Dietary supplement | Placebo high VKA, Vitamin K2 Low VKA, Vitamin K2 high VKA, placebo low VKA |
Primary outcome
INR
Time frame: change from baseline at two months
Prothrombin time
INR
Time frame: change from baseline at four months
prothrombin time
8 secondary outcomes
c/uc osteocalcin ratio
Time frame: change from baseline at two months
FVII from plasma
Time frame: change from baseline at two months
FII
Time frame: change from baseline at two months
Plasma vitamin K levels
Time frame: change from base-line at two months
c/uc osteocalcin ratio
Time frame: change from baseline at four months
FVII
Time frame: change from baseline at four months
FII
Time frame: change from baseline at four months
Plasma vitamin K level
Time frame: change from baseline at four 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 8 Apr 2014.
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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.
Kirsti Tiihonen, PhD study director
Danisco Sweeteners Oy
Ludovic Drouet, Professor study chair
IVS/CREATIF, Hopital Lariboisiere
Claire Bal dit Sollier study chair
IVS/CREATIF, Hopital Lariboisiere
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 Vitamin K2 in people with Thrombosis, run by Danisco at 1 site in France.
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 5 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 8 Apr 2014. 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 France. 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 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?
INR (time frame: change from baseline at two months). The study lists 2 primary outcomes in all. 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 8 Apr 2014.