Clinical trial NCT01533441: Vitamin K2 Intervention in Patients With Vitamin K Antagonists
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombosis
Keywords: anticoagulant therapy
INR
vitamin K2
vitamin K antagonist
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: INR
timeFrame: change from baseline at two months
measure: INR
timeFrame: change from baseline at four months
Secondary outcomes:
measure: c/uc osteocalcin ratio
timeFrame: change from baseline at two months
measure: FVII from plasma
timeFrame: change from baseline at two months
measure: FII
timeFrame: change from baseline at two months
measure: Plasma vitamin K levels
timeFrame: change from base-line at two months
measure: c/uc osteocalcin ratio
timeFrame: change from baseline at four months
measure: FVII
timeFrame: change from baseline at four months
measure: FII
timeFrame: change from baseline at four months
measure: Plasma vitamin K level
timeFrame: change from baseline at four months
Other outcomes:
Locations:
city: Paris
country: France
facility: Unite de Recherches Therapeutiques, Hopital Lariboisiere
Study officials:
affiliation: Danisco Sweeteners Oy
name: Kirsti Tiihonen, PhD
role: STUDY_DIRECTOR
affiliation: IVS/CREATIF, Hopital Lariboisiere
name: Ludovic Drouet, Professor
role: STUDY_CHAIR
affiliation: IVS/CREATIF, Hopital Lariboisiere
name: Claire Bal dit Sollier
role: STUDY_CHAIR
References: