Condition category
Circulatory System
Date applied
04/03/2011
Date assigned
28/03/2011
Last edited
22/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Low intake of vitamin K in the diet has been linked to a higher risk of heart attacks and strokes. This may be because vitamin K is important in keeping blood vessels in good health; low levels of vitamin K are associated with stiffer blood vessels and deposits of calcium in the blood vessel wall. Vitamin K may also be important in keeping nerves working well which are important in maintaining balance and avoiding falls. It is not known whether taking extra vitamin K (as a tablet) can improve balance or blood vessel health, so the aim of this study is to test whether taking a vitamin K tablet for 6 months improves blood vessel health and improves balance in older people who have had (or are at risk of) a heart attack or stroke.

Who can participate?
Older people aged 70 and over who have had (or are at risk of) a heart attack or stroke

What does the study involve?
Participants are randomly allocated to take either vitamin K or a matching placebo (dummy) tablet once a day for 6 months. They are then followed up to assess their blood vessel health and balance.

What are the possible benefits and risks of participating?
If vitamin K improves blood vessel health, it might reduce the risk of heart attacks and strokes, but this study is too small to show this directly. Vitamin K is safe with no known side effects. It can interfere with the action of the drug warfarin, which is why patients on warfarin are excluded from the study.

Where is the study run from?
Ninewells Hospital (UK)

When is the study starting and how long is it expected to run for?
August 2011 to March 2013

Who is funding the study?
Chest Heart and Stroke Scotland (UK)

Who is the main contact?
Dr Miles Witham
m.witham@dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miles Witham

ORCID ID

http://orcid.org/0000-0002-1967-0990

Contact details

Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)13 8263 2436
m.witham@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R11/A137

Study information

Scientific title

Vitamin K to improve markers of vascular health and physical function in older people with vascular disease: a randomised controlled trial

Acronym

KIMVASC

Study hypothesis

To test whether vitamin K supplementation improves markers of vascular health in older people with vascular disease.

Ethics approval

East of Scotland NHS Research Ethics Committee, 12/09/2011, ref: 11/ES/0009

Study design

Parallel-group double-blind placebo-controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Vascular disease

Intervention

Vitamin K2 (MK7 subtype) 100 mcg per day or placebo.

Added 18/08/2017:
Participants are randomised to take either:
1. Vitamin K2 (MK7 subtype) given as 100 mcg oral tablet once a day for 6 months
2. Matching placebo tablet, given once a day for 6 months
Treatment in both arms given for 6 months, which is also the length of follow up.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin K

Primary outcome measures

Flow-mediated dilatation of the brachial artery measured at baseline and 6 months

Secondary outcome measures

Measured at baseline, 3 months and 6 months:
1. Markers of vascular function:
1.1. Arterial stiffness and reflectivity, measured using pulse wave velocity and augmentation index
1.2. Carotid intima-media thickness and compliance
2. Markers of vascular prognosis: brain natriuretic peptide (BNP), office blood pressure (BP) (lying and standing), total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol
3. Markers of inflammation: high-sensitivity C-reactive protein
4. Serum MK7 levels, measured by high-performance liquid chromatography (HPLC)
5. Markers of physical function:
5.1. Short Physical Performance Battery; predicts disability, falls and death
5.2. Balance, measured using force plate analysis
5.3. Grip strength as a test of maximal muscle strength; predicts institutionalisation and death

Overall trial start date

01/08/2011

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 70 and over
2. At least one of the conditions:
2.1. Hypertension (based on recorded diagnosis from primary or secondary care)
2.2. Diabetes mellitus (based on recorded diagnosis from primary or secondary care)
3. Established vascular disease: myocardial infarction [based on symptoms of ischaemia or electrocardiogram (ECG) changes, plus rise in cardiac enzymes]
4. Percutaneous transluminal coronary angioplasty
5. Coronary artery bypass grafting
6. Stroke/transient ischaemic attack (TIA) (diagnosis established in secondary care)
7. Peripheral vascular disease (symptoms of peripheral ischaemia and either a previous ankle/brachial pressure index < 0.7 or previous evidence of arterial stenosis on angiography or ultrasound)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Atrial fibrillation
2. Taking warfarin
3. Unable to give written informed consent
4. Unable to walk without human assistance (walking aids are permitted)

Recruitment start date

01/09/2011

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Tayside Academic Sciences Collaboration (UK)

Sponsor details

Level 3 Residences
Geroge Pirie Way
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)13 8274 0489
TASC@dundee.ac.uk

Sponsor type

University/education

Website

http://www.tasc-research.org.uk

Funders

Funder type

Charity

Funder name

Chest Heart and Stroke Scotland (ref: R11/A137)

Alternative name(s)

CHSS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Manuscript accepted for publication.

IPD sharing statement
The datasets generated during and/or analysed during the current study are available upon request from Dr Miles Witham (m.witham@dundee.ac.uk). Anonymised individual participant data on all those randomised will be made available to bona fide researchers for non-commercial use, subject to sight of an analysis plan and subject to appropriate data sharing agreements and approval from the trial Sponsor.

Intention to publish date

09/11/2017

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN93213492_BasicResults_04Aug2017.pdf

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26892582

Publication citations

Additional files

Editorial Notes

22/08/2017: The basic results of this trial have been uploaded as an additional file. 18/08/2017: Interventions details and plain English summary added. 09/08/2017: Ethics approval details added. 04/08/2017: Recruitment dates confirmed, IPD sharing statement added. 16/11/2016: Publication reference added.