Vitamin K to improve markers of vascular health and physical function in older people with vascular disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93213492

Enrollment

Registered

2011-03-28

Start date

2011-09-01

Completion date

Unknown

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular disease Circulatory System Vascular disease

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Flow-mediated dilatation of the brachial artery measured at baseline and 6 months	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026