Condition category
Haematological Disorders
Date applied
17/03/2008
Date assigned
31/03/2008
Last edited
02/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr FJM van der Meer

ORCID ID

Contact details

Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 3901
f.j.m.van_der_meer@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P07.243

Study information

Scientific title

Acronym

VIKS-2A

Study hypothesis

The anti-coagulation treatment with vitamin K antagonists will be more stable and safer with the supplementation of a low daily dose of vitamin K.

Ethics approval

Ethics approval received from the Medical Ethics Committee of Leiden University Medical Center on the 4th March 2008.

Study design

Randomised double-blind placebo-controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anti-coagulant treatment

Intervention

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 vitamin K1 (oral), 1 dd
Group 3: 200 µg vitamin K1 (oral), 1 dd
Control group: placebo (oral), 1 dd

The duration of the treatment is flexible, as is the inclusion period. Follow-up will take place six months after the closure of the inclusion period. This means the first patients will receive vitamin K or placebo for six months and the time the inclusion will take. The last patients will only receive vitamin K or placebo for six months.

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin K supplementation

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/04/2008

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 patients

Participant 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

Recruitment start date

01/04/2008

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

Sponsor details

P.O. Box 300
The Hague
2501 CH
Netherlands
+31 (0)70 315 5555
info@hartstichting.nl

Sponsor type

Charity

Website

http://www.hartstichting.nl

Funders

Funder type

Charity

Funder name

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes