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Vitamin K2 Intervention in Patients With Vitamin K Antagonists

NCT01533441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-04-08

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin K2

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

Sponsors & Collaborators

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Kirsti Tiihonen, PhD · Danisco Sweeteners Oy

  • Ludovic Drouet, Professor · IVS/CREATIF, Hopital Lariboisiere

  • Claire Bal dit Sollier · IVS/CREATIF, Hopital Lariboisiere

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01533441 on ClinicalTrials.gov