NCT01533441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

February 3, 2012

Last Update Submit

April 7, 2014

Conditions

Thrombosis

Keywords

anticoagulant therapyINRvitamin K2vitamin K antagonist

Outcome Measures

Primary Outcomes (2)

  • INR

    Prothrombin time

    change from baseline at two months

  • INR

    prothrombin time

    change from baseline at four months

Secondary Outcomes (8)

  • c/uc osteocalcin ratio

    change from baseline at two months

  • FVII from plasma

    change from baseline at two months

  • FII

    change from baseline at two months

  • Plasma vitamin K levels

    change from base-line at two months

  • c/uc osteocalcin ratio

    change from baseline at four months

  • +3 more secondary outcomes

Study Arms (4)

placebo low VKA

PLACEBO COMPARATOR
Dietary Supplement: Vitamin K2

Placebo high VKA

PLACEBO COMPARATOR

Microcrystalline cellulose

Dietary Supplement: Vitamin K2

Vitamin K2 Low VKA

ACTIVE COMPARATOR
Dietary Supplement: Vitamin K2

Vitamin K2 high VKA

ACTIVE COMPARATOR
Dietary Supplement: Vitamin K2

Interventions

Vitamin K2DIETARY_SUPPLEMENT

4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention

Also known as: phylloquinone,, menaquinone
Placebo high VKAVitamin K2 Low VKAVitamin K2 high VKAplacebo low VKA

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • treated with anticoagulants
  • INR range between 2-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unite de Recherches Therapeutiques, Hopital Lariboisiere

Paris, France

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Vitamin K 2Vitamin K 1

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Kirsti Tiihonen, PhD

    Danisco Sweeteners Oy

    STUDY DIRECTOR

  • Ludovic Drouet, Professor

    IVS/CREATIF, Hopital Lariboisiere

    STUDY CHAIR

  • Claire Bal dit Sollier

    IVS/CREATIF, Hopital Lariboisiere

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

FR(1)