Vitamin K2 Intervention in Patients With Vitamin K Antagonists

Thrombosis Clinical Trial

— SAFEK  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533441
• Other study ID #: SAFE K study
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2012
• Last updated: April 7, 2014
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Thrombosis

Intervention

Dietary Supplement:
• Vitamin K2
4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention

Locations

Country	Name	City	State
France	Unite de Recherches Therapeutiques, Hopital Lariboisiere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INR	Prothrombin time	change from baseline at two months	Yes
Primary	INR	prothrombin time	change from baseline at four months	Yes
Secondary	c/uc osteocalcin ratio	immunoassay method	change from baseline at two months	No
Secondary	FVII from plasma	chronometric method	change from baseline at two months	Yes
Secondary	FII	chronometric method	change from baseline at two months	Yes
Secondary	Plasma vitamin K levels	HPLC	change from base-line at two months	No
Secondary	c/uc osteocalcin ratio	immunoassay method	change from baseline at four months	No
Secondary	FVII	chronometric method	change from baseline at four months	Yes
Secondary	FII	chronometric method	change from baseline at four months	Yes
Secondary	Plasma vitamin K level	HPLC	change from baseline at four months	No