Thrombosis
Conditions
Keywords
anticoagulant therapy, INR, vitamin K2, vitamin K antagonist
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTVitamin K2
4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
Sponsors
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* treated with anticoagulants * INR range between 2-3 * TTR (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INR | change from baseline at two months | Prothrombin time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FVII from plasma | change from baseline at two months | chronometric method |
| FII | change from baseline at two months | chronometric method |
| c/uc osteocalcin ratio | change from baseline at two months | immunoassay method |
| FVII | change from baseline at four months | chronometric method |
| Plasma vitamin K level | change from baseline at four months | HPLC |
| Plasma vitamin K levels | change from base-line at two months | HPLC |
Countries
France
Outcome results
None listed