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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01533441
First received: February 3, 2012
Last updated: April 7, 2014
Last verified: April 2014
  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:


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


Enrollment: 50
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: April 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

Locations
France
Unite de Recherches Therapeutiques, Hopital Lariboisiere
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: April 7, 2014
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
Vitamin MK 7
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 April 21, 2014