Vitamin K2 Intervention in Patients With Vitamin K Antagonists (SAFEK)

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Dietary supplement: Vitamin K2

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Unité de Recherches Thérapeutiques, Hôpital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danisco
• Investigators: Study Director: Kirsti Tiihonen, PhD, Danisco Sweeteners Oy; Study Chair: Ludovic Drouet, Professor, IVS/CREATIF, Hopital Lariboisiere; Study Chair: Claire Bal dit Sollier, IVS/CREATIF, Hopital Lariboisiere

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: April 7, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: INR; vitamin K antagonist; anticoagulant therapy; vitamin K2
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Vitamins; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamin K 1; Vitamin K 2
• Other Study ID Numbers: SAFE K study