Condition category
Circulatory System
Date applied
04/03/2011
Date assigned
28/03/2011
Last edited
16/11/2016
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 Miles Witham

ORCID ID

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

Tayside Research Ethics Committee B- approval pending as of 07/03/2011

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 below to request a patient information sheet

Condition

Vascular disease

Intervention

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

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin K

Primary outcome measures

Change in flow-mediated dilatation of the brachial artery between baseline and 6 months

Secondary outcome measures

Change between baseline, 3 months and 6 months for:
1. Markers of vascular function
1.1. Pulse wave velocity and augmentation index to measure arterial stiffness and reflectivity
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. Age 70 and over
2. At least one of the condition
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

01/08/2011

Recruitment end date

31/03/2013

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 (UK) (ref: R11/A137)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Manuscript accepted for publication

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes

16/11/2016: Publication reference added.