Vitamin K2 Intervention in Patients With Vitamin K Antagonists

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)

Conditions
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Thrombosis

Intervention / Treatment
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* Dietary Supplement: Vitamin K2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo low VKA<br> | Dietary Supplement: Vitamin K2<br>* 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention<br>* Other names: menaquinone;|
| Placebo Comparator: Placebo high VKA<br>Microcrystalline cellulose | Dietary Supplement: Vitamin K2<br>* 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention<br>* Other names: menaquinone;|
| Active Comparator: Vitamin K2 Low VKA<br> | Dietary Supplement: Vitamin K2<br>* 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention<br>* Other names: menaquinone;|
| Active Comparator: Vitamin K2 high VKA<br> | Dietary Supplement: Vitamin K2<br>* 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention<br>* Other names: menaquinone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR | Prothrombin time | change from baseline at two months | 
| INR | prothrombin time | change from baseline at four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| c/uc osteocalcin ratio | immunoassay method | change from baseline at two months | 
| FVII from plasma | chronometric method | change from baseline at two months | 
| FII | chronometric method | change from baseline at two months | 
| Plasma vitamin K levels | HPLC | change from base-line at two months | 
| c/uc osteocalcin ratio | immunoassay method | change from baseline at four months | 
| FVII | chronometric method | change from baseline at four months | 
| FII | chronometric method | change from baseline at four months | 
| Plasma vitamin K level | HPLC | change from baseline at four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulant therapy, INR, vitamin K2, vitamin K antagonist