Unite de Recherches Therapeutiques, Hopital Lariboisiere
Paris, France
NCT Number: NCT01533441
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.
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Notify Me50 year–85 year
All sexes
Interventional
Phase 2
Paris, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
Other names: phylloquinone,, menaquinone
Time frame: change from baseline at two months
Prothrombin time
Time frame: change from baseline at four months
prothrombin time
Time frame: change from baseline at two months
immunoassay method
Time frame: change from baseline at two months
chronometric method
Time frame: change from baseline at two months
chronometric method
Time frame: change from base-line at two months
HPLC
Time frame: change from baseline at four months
immunoassay method
Time frame: change from baseline at four months
chronometric method
Time frame: change from baseline at four months
chronometric method
Time frame: change from baseline at four months
HPLC
Danisco
Industry
Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)
Acronym: SAFEK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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