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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo low VKA | Placebo Comparator |
| |
| Placebo high VKA | Placebo Comparator | Microcrystalline cellulose |
|
| Vitamin K2 Low VKA | Active Comparator |
| |
| Vitamin K2 high VKA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 | Dietary Supplement | 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| INR | Prothrombin time | change from baseline at two months |
| INR | prothrombin time | change from baseline at four months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsti Tiihonen, PhD | Danisco Sweeteners Oy | Study Director |
| Ludovic Drouet, Professor | IVS/CREATIF, Hopital Lariboisiere | Study Chair |
| Claire Bal dit Sollier | IVS/CREATIF, Hopital Lariboisiere | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unite de Recherches Therapeutiques, Hopital Lariboisiere | Paris | France |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| D010837 | Vitamin K 1 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |