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Completed

NCT Number: NCT01533441

Vitamin K2 Intervention in Patients With Vitamin K Antagonists

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unite de Recherches Therapeutiques, Hopital Lariboisiere

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin K2

Dietary Supplement

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

Other names: phylloquinone,, menaquinone

Primary outcomes

  1. INR

    Time frame: change from baseline at two months

    Prothrombin time

  2. INR

    Time frame: change from baseline at four months

    prothrombin time

Secondary outcomes

  1. c/uc osteocalcin ratio

    Time frame: change from baseline at two months

    immunoassay method

  2. FVII from plasma

    Time frame: change from baseline at two months

    chronometric method

  3. FII

    Time frame: change from baseline at two months

    chronometric method

  4. Plasma vitamin K levels

    Time frame: change from base-line at two months

    HPLC

  5. c/uc osteocalcin ratio

    Time frame: change from baseline at four months

    immunoassay method

  6. FVII

    Time frame: change from baseline at four months

    chronometric method

  7. FII

    Time frame: change from baseline at four months

    chronometric method

  8. Plasma vitamin K level

    Time frame: change from baseline at four months

    HPLC

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study 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)

Acronym: SAFEK

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2012
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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