SAFEK: Vitamin K2 Intervention in Patients With Vitamin K Antagonists

Sponsor

Danisco (Industry)

Overall Status

Completed

CT.gov ID

NCT01533441

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Dietary Supplement: Vitamin K2	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo low VKA	Dietary Supplement: Vitamin K2 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention Other Names: phylloquinone, menaquinone
Placebo Comparator: Placebo high VKA Microcrystalline cellulose	Dietary Supplement: Vitamin K2 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention Other Names: phylloquinone, menaquinone
Active Comparator: Vitamin K2 Low VKA	Dietary Supplement: Vitamin K2 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention Other Names: phylloquinone, menaquinone
Active Comparator: Vitamin K2 high VKA	Dietary Supplement: Vitamin K2 4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention Other Names: phylloquinone, menaquinone

Outcome Measures

Primary Outcome Measures

INR [change from baseline at two months]
Prothrombin time
INR [change from baseline at four months]
prothrombin time

Secondary Outcome Measures

c/uc osteocalcin ratio [change from baseline at two months]
immunoassay method
FVII from plasma [change from baseline at two months]
chronometric method
FII [change from baseline at two months]
chronometric method
Plasma vitamin K levels [change from base-line at two months]
HPLC
c/uc osteocalcin ratio [change from baseline at four months]
immunoassay method
FVII [change from baseline at four months]
chronometric method
FII [change from baseline at four months]
chronometric method
Plasma vitamin K level [change from baseline at four months]
HPLC

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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