Vitamin K2 Intervention in Patients With Vitamin K Antagonists

Phase 2

Completed

• Conditions: Thrombosis
• Interventions: Dietary Supplement: Vitamin K2

• Registration Number: NCT01533441
• Lead Sponsor: Danisco

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin K2 Low VKA	Vitamin K2	-
Vitamin K2 high VKA	Vitamin K2	-
placebo low VKA	Vitamin K2	-
Placebo high VKA	Vitamin K2	Microcrystalline cellulose

Primary Outcome Measures

Name	Time	Method
INR	change from baseline at four months	prothrombin time

Secondary Outcome Measures

Name	Time	Method
FVII from plasma	change from baseline at two months	chronometric method
c/uc osteocalcin ratio	change from baseline at four months	immunoassay method
FII	change from baseline at four months	chronometric 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

Trial Locations

Locations (1)

Unite de Recherches Therapeutiques, Hopital Lariboisiere; 🇫🇷 Paris, France