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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Vitamin K2
Sponsored by
Danisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thrombosis focused on measuring anticoagulant therapy, INR, vitamin K2, vitamin K antagonist

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unite de Recherches Therapeutiques, Hopital Lariboisiere

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo low VKA

Placebo high VKA

Vitamin K2 Low VKA

Vitamin K2 high VKA

Arm Description

Microcrystalline cellulose

Outcomes

Primary Outcome Measures

INR
Prothrombin time
INR
prothrombin time

Secondary Outcome Measures

c/uc osteocalcin ratio
immunoassay method
FVII from plasma
chronometric method
FII
chronometric method
Plasma vitamin K levels
HPLC
c/uc osteocalcin ratio
immunoassay method
FVII
chronometric method
FII
chronometric method
Plasma vitamin K level
HPLC

Full Information

First Posted
February 3, 2012
Last Updated
April 7, 2014
Sponsor
Danisco
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1. Study Identification

Unique Protocol Identification Number
NCT01533441
Brief Title
Vitamin K2 Intervention in Patients With Vitamin K Antagonists
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danisco

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
anticoagulant therapy, INR, vitamin K2, vitamin K antagonist

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo low VKA
Arm Type
Placebo Comparator
Arm Title
Placebo high VKA
Arm Type
Placebo Comparator
Arm Description
Microcrystalline cellulose
Arm Title
Vitamin K2 Low VKA
Arm Type
Active Comparator
Arm Title
Vitamin K2 high VKA
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Other Intervention Name(s)
phylloquinone,, menaquinone
Intervention Description
4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
Primary Outcome Measure Information:
Title
INR
Description
Prothrombin time
Time Frame
change from baseline at two months
Title
INR
Description
prothrombin time
Time Frame
change from baseline at four months
Secondary Outcome Measure Information:
Title
c/uc osteocalcin ratio
Description
immunoassay method
Time Frame
change from baseline at two months
Title
FVII from plasma
Description
chronometric method
Time Frame
change from baseline at two months
Title
FII
Description
chronometric method
Time Frame
change from baseline at two months
Title
Plasma vitamin K levels
Description
HPLC
Time Frame
change from base-line at two months
Title
c/uc osteocalcin ratio
Description
immunoassay method
Time Frame
change from baseline at four months
Title
FVII
Description
chronometric method
Time Frame
change from baseline at four months
Title
FII
Description
chronometric method
Time Frame
change from baseline at four months
Title
Plasma vitamin K level
Description
HPLC
Time Frame
change from baseline at four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsti Tiihonen, PhD
Organizational Affiliation
Danisco Sweeteners Oy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ludovic Drouet, Professor
Organizational Affiliation
IVS/CREATIF, Hopital Lariboisiere
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claire Bal dit Sollier
Organizational Affiliation
IVS/CREATIF, Hopital Lariboisiere
Official's Role
Study Chair
Facility Information:
Facility Name
Unite de Recherches Therapeutiques, Hopital Lariboisiere
City
Paris
Country
France

12. IPD Sharing Statement

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Vitamin K2 Intervention in Patients With Vitamin K Antagonists

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