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A study to find the optimal dose for vitamin K supplementation in patients being treated with vitamin K antagonists to create an anti-coagulation effect

A study to find the optimal dose for vitamin K supplementation in patients being treated with vitamin K antagonists to create an anti-coagulation effect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37109430
Enrollment
400
Registered
2008-03-31
Start date
2008-04-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-coagulant treatment Haematological Disorders Other coagulation defects

Interventions

The participants will be randomly allocated to the following four groups in equal numbers: Group 1: 100 µg vitamin K1 (oral), 1 capsule per day (1 dd) Group 2: 150 µg v

Sponsors

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Start treatment with vitamin K antagonists less then four weeks before inclusion 2. Treatment with vitamin K antagonists for a minimal period of six months, with the therapeutic range of International normalised ratio (INR) between 2.5 anf 3.5 3. Aged between 18 and 85 years, either sex 4. Measurement of the INR by the Thrombosis Service Leiden 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Treatment for liver failure 2. Dialysis, both peritoneal and haemodialysys 3. Pregnancy, or wish to get pregnant; lactational period 4. Known to have a chronic condition with a life expectancy of less than six months 5. An expected interruption of treatment with oral anti-coagulants for one week or longer 6. Participation in the self-management protocol

Design outcomes

Primary

MeasureTime frame
Quality of anti-coagulant treatment expressed as time in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion period.

Secondary

MeasureTime frame
Number of INRs in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion period.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026