Vitamin K therapy to improve vascular health in patients with chronic kidney disease

Vitamin K therapy to improve vascular health in patients with chronic kidney disease: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21444964

Enrollment

166

Registered

2015-02-24

Start date

2015-06-01

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

Chronic kidney disease stages 3b and 4 Urological and Genital Diseases

Interventions

400 mcg once daily oral vitamin K2 (MK7 subtype) vs matching placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. CKD stages 3b or 4 (eGFR of >15 ml/min and <45 ml/min by MDRD4 equation)

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation 2. Taking warfarin (which antagonises vitamin K) or other coumadin derivatives. 3. Taking vitamin K 4. Unable to give written informed consent 5. Currently enrolled in another trial, or within 30 days of completing another trial 6. Pregnant or (if female and pre-menopausal) not using reliable contraception

Design outcomes

Primary

Measure	Time frame
Between-group difference in carotid-femoral pulse wave velocity (PWV) at 12 months using the Sphygmocor system	—

Secondary

Measure	Time frame
All measured at 0,6 and 12 months except for aortic radiography: 1. Vascular health: 1.1. Office and 24 hour blood pressure 1.2. B-type natriuretic peptide 1.3. Central systolic blood pressure and augmentation index derived from applanation tonometry at the radial artery using the Sphygmocor system. 1.4. Pulse wave velocity at 6 months (in addition to the primary outcome measured at 12 months) 2. Insulin and glucose levels to calculate insulin resistance using HOMA-IR 3. Marker of effect of vitamin K: dp-ucMGP levels. 4. Calcium and bone metabolism and turnover: 4.1. Osteocalcin 4.2. Tartrate resistant acid phosphatase-5b 4.3. Parathyroid hormone 4.4. Fetuin 4.5. Fibroblast growth factor-23 4.6. 25-hydroxyvitamin D 4.7. 1,25-hydroxyvitamin D 5. Renal function: We will measure serum creatinine, and urinary protein/creatinine ratio on a spot urine sample at each timepoint 6. Radiological calcification: We will perform lateral abdominal radiography at baseline and 12 months to assess aortic calcification. 7. Physical function: 7.1. Short physical performance battery 7.2 Grip strength at each timepoint 7.3. Monthly falls diary to prospectively record falls	—

Measure

Time frame

All measured at 0,6 and 12 months except for aortic radiography: 1. Vascular health: 1.1. Office and 24 hour blood pressure 1.2. B-type natriuretic peptide 1.3. Central systolic blood pressure and augmentation index derived from applanation tonometry at the radial artery using the Sphygmocor system. 1.4. Pulse wave velocity at 6 months (in addition to the primary outcome measured at 12 months) 2. Insulin and glucose levels to calculate insulin resistance using HOMA-IR 3. Marker of effect of vitamin K: dp-ucMGP levels. 4. Calcium and bone metabolism and turnover: 4.1. Osteocalcin 4.2. Tartrate resistant acid phosphatase-5b 4.3. Parathyroid hormone 4.4. Fetuin 4.5. Fibroblast growth factor-23 4.6. 25-hydroxyvitamin D 4.7. 1,25-hydroxyvitamin D 5. Renal function: We will measure serum creatinine, and urinary protein/creatinine ratio on a spot urine sample at each timepoint 6. Radiological calcification: We will perform lateral abdominal radiography at baseline and 12 months to assess aortic calcification. 7. Physical function: 7.1. Short physical performance battery 7.2 Grip strength at each timepoint 7.3. Monthly falls diary to prospectively record falls

—

Countries

United Kingdom

Contacts

Public ContactMiles Witham

Miles.Witham@newcastle.ac.uk01382 383086

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026