|
ISRCTN
|
ISRCTN93213492
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Vitamin K to improve markers of vascular health and physical function in older people with vascular disease
|
|
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
|
|
Serial number at source
|
R11/A137
|
|
Study hypothesis
|
To test whether vitamin K supplementation improves markers of vascular health in older people with vascular disease
|
|
Lay summary
|
|
|
Ethics approval
|
Tayside Research Ethics Committee B- approval pending as of 07/03/2011
|
|
Study design
|
Parallel group double-blind placebo controlled randomised trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Vascular disease
|
|
Participants - 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)
|
|
Participants - 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)
|
|
Anticipated start date
|
01/08/2011
|
|
Anticipated end date
|
31/03/2013
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
80
|
|
Interventions
|
Vitamin K2 (MK7 subtype) 100 mcg per day or placebo
|
|
Primary outcome measure(s)
|
Change in flow-mediated dilatation of the brachial artery between baseline and 6 months
|
|
Secondary outcome measure(s)
|
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
|
|
Sources of funding
|
Chest Heart and Stroke Scotland (UK) (ref: R11/A137)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Miles
Witham
|
|
Address
|
Ageing and Health, Ninewells Hospital
|
|
City/town
|
Dundee
|
|
Zip/Postcode
|
DD1 9SY
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)13 8263 2436
|
|
Fax
|
+44 (0)13 8266 0675
|
|
Email
|
m.witham@dundee.ac.uk
|
|
Sponsor
|
Tayside Academic Sciences Collaboration (UK)
|
|
Address
|
Level 3 Residences, Geroge Pirie Way, Ninewells Hospital
|
|
City/town
|
Dundee
|
|
Zip/Postcode
|
DD1 9SY
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)13 8274 0489
|
|
Fax
|
+44 (0)13 8249 6207
|
|
Email
|
TASC@dundee.ac.uk
|
|
Sponsor website:
|
http://www.tasc-research.org.uk
|
|
Date applied
|
04/03/2011
|
|
Last edited
|
28/03/2011
|
|
Date ISRCTN assigned
|
28/03/2011
|
