Condition category
Haematological Disorders
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively 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 Hilary Wynne

ORCID ID

Contact details

Newcastle upon Tyne Hospitals NHS Foundation Trust
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8579

Study information

Scientific title

Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin K: a single centre randomised controlled trial

Acronym

Study hypothesis

To investigate whether daily supplementation with vitamin K improves the stability of anticoagulation control in patients on chronic therapy with warfarin.

Ethics approval

Sunderland Research Ethics Committee, 08/06/2009, ref: 09/H0904/25

Study design

Single-centre non-randomised observational screening cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please contact Maggie Fearby on +44 (0)191 282 1632 to request a patient information sheet

Condition

Topic: Blood; Subtopic: Blood (all Subtopics); Disease: Non-malignant haematology

Intervention

Randomised (blinded) to vitamin K/placebo 150 µg orally once daily for 6 months. Follow-up at 1, 2, 4, 8, 12, 16, 20, and 24 weeks post initial dose.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin K

Primary outcome measures

Percent time within target INR (calculated by the method of interpolation) for the study period, measured at baseline and weeks 1, 2, 4, 8, 12, 16, 20 and 24 weeks.

Secondary outcome measures

1. Clinical events of major (defined as bleeding that led to loss of 2 units of blood over a 7 day period
2. Days attending anticoagulation clinic to monitor and achieve target International Normalised Ratio (INR)
3. Markers of lack of efficacy including recurrent thrombosis
4. The number of warfarin dose changes
5. Quality of life questionnaires recorded at baseline and repeated at the end of the study

Overall trial start date

01/07/2010

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Long term warfarin therapy
2. Aged greater than or equal to 18 years
3. Male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 180

Participant exclusion criteria

1. Abnormal hepatic or renal function
2. Impairment of cognitive function

Recruitment start date

01/07/2010

Recruitment end date

01/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

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

30/09/2016: No publications found, verifying study status with principal investigator