Vitamin K2 Intervention in Patients With Vitamin K Antagonists - Full Text View

Purpose

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	Intervention	Phase
Thrombosis	Dietary Supplement: Vitamin K2	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Vitamin K

Drug Information available for: Menadione Phytonadione Vitamin K1

U.S. FDA Resources

Further study details as provided by Danisco:

Primary Outcome Measures:

INR [ Time Frame: change from baseline at two months ] [ Designated as safety issue: Yes ]
Prothrombin time
INR [ Time Frame: change from baseline at four months ] [ Designated as safety issue: Yes ]
prothrombin time

Secondary Outcome Measures:

c/uc osteocalcin ratio [ Time Frame: change from baseline at two months ] [ Designated as safety issue: No ]
immunoassay method
FVII from plasma [ Time Frame: change from baseline at two months ] [ Designated as safety issue: Yes ]
chronometric method
FII [ Time Frame: change from baseline at two months ] [ Designated as safety issue: Yes ]
chronometric method
Plasma vitamin K levels [ Time Frame: change from base-line at two months ] [ Designated as safety issue: No ]
HPLC
c/uc osteocalcin ratio [ Time Frame: change from baseline at four months ] [ Designated as safety issue: No ]
immunoassay method
FVII [ Time Frame: change from baseline at four months ] [ Designated as safety issue: Yes ]
chronometric method
FII [ Time Frame: change from baseline at four months ] [ Designated as safety issue: Yes ]
chronometric method
Plasma vitamin K level [ Time Frame: change from baseline at four months ] [ Designated as safety issue: No ]
HPLC

Estimated Enrollment:	52
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533441

Contacts

Contact: Jean-Francois Bergmann, Professor	+33 149956341	jf.bergmann@lrb.aphp.fr
Contact: Guy Simoneau, MD	+33 149956346

Locations

France
Unite de Recherches Therapeutiques, Hopital Lariboisiere	Recruiting
Paris, France

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Danisco
ClinicalTrials.gov Identifier:	NCT01533441 History of Changes
Other Study ID Numbers:	SAFE K study
Study First Received:	February 3, 2012
Last Updated:	February 14, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Danisco:

anticoagulant therapy
INR
vitamin K2
vitamin K antagonist

Additional relevant MeSH terms:

Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamin K 1
Vitamin K
Vitamins
Vitamin K 2
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

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