Vitamin K in kidney transplant organ recipients: Investigating the effect on vessel stiffness

Conditions

Renal transplant recipients Surgery Renal transplant recipients

Lees JS, Rankin AJ, Gillis KA, Zhu LY, Mangion K, Rutherford E, Roditi GH, Witham MD, Chantler D, Panarelli M, Jardine AG, Mark PB.

2021-05-0223 citations

10.1111/ajt.16566

Vitamin K for kidney transplant organ recipients: investigating vessel stiffness (ViKTORIES): study rationale and protocol of a randomised controlled trial

Jennifer S. Lees, Kenneth Mangion, Elaine Rutherford, Miles D. Witham, Rosemary Woodward et al. (10 authors)

Open Heart2020-07-019 citations

10.1136/openhrt-2019-001070

MO011A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF VITAMIN K SUPPLEMENTATION TO IMPROVE VASCULAR HEALTH IN KIDNEY TRANSPLANT RECIPIENTS

Jennifer S. Lees, Alastair J. Rankin, Keith Gillis, Luke Zhu, Elaine Rutherford et al. (9 authors)

Nephrology Dialysis Transplantation2020-06-01

10.1093/ndt/gfaa140.mo011

Interventions

Most participants have a screening visit combined with a baseline visit, and if happy to participate, have blood and urine tests taken, blood vessel stiffness measured using a small, plastic pencil-sh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female of non-child-bearing potential aged 18 years or over 2. Functioning renal transplant, transplanted > 12 months 3. eGFR >15ml/min by CKD-EPI equation

Exclusion criteria

Exclusion criteria: 1. Inability to give written informed consent 2. Atrial fibrillation 3. Taking warfarin (vitamin K antagonist) 4. Taking vitamin K or indication for vitamin K 5. Allergy or intolerance to gelatine, lactose or cellulose 6. Breast-feeding or women of child-bearing potential 7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency 8. Life expectancy <12 months 9. Contraindications to MRI scan

Design outcomes

Primary

Measure	Time frame
Vascular stiffness is measured using the aortic distensibility on MRI scan at 12 months of treatment.	—

Secondary

Measure	Time frame
1. Carotid-femoral pulse wave velocity is measured using SphygmoCor XCEL PWA & PWV system at 12 months of treatment 2. Left ventricular mass, cardiac fibrosis, left atrial volume, global longitudinal strain, pulse wave velocity are measured using Cardiac MRI at 12 months of treatment 3. Marker of vitamin K status is measured using dp-ucMGP levels, Elastin degradation products (EDPs) at 12 months of treatment 4. Vascular health is measured using office (brachial) blood pressure, electrocardiogram (ECG), augmentation index measured by applanation tonometry at the radial artery at 12 months of treatment 5. Coronary and aortic calcification is measured using cardiac CT scan at 12 months of treatment 6. Bone metabolism and turnover measured using calcium, phosphate, parathyroid hormone, fibroblast growth factor-23 (FGF-23), 25-hydroxyvitamin D, 1,25-hydroxyvitamin D, osteocalcin, fetuin, bone morphogenetic protein (BMP), Tartrate resistant acid phosphatase-5b (TRAP-5b) at 12 months of treatment 7. Cardiovascular markers are measured using high-sensitivity troponin and brain natriuretic peptide at 12 months of treatment 8. Endothelial function is measured using Asymmetric Dimethylarginine (ADMA) at 12 months of treatment 9. Dietary vitamin K content is estimated at baseline using 28-day food diary 10. Transplant function is measured using blood tests for urea and electrolytes at 12 months of treatment 11. Proteinuria is measured using urinary protein to creatinine ratio at 12 months of treatment 12. Quality of life is measured using the EQ-5D at 12 months of treatment	—

Measure

Time frame

1. Carotid-femoral pulse wave velocity is measured using SphygmoCor XCEL PWA & PWV system at 12 months of treatment 2. Left ventricular mass, cardiac fibrosis, left atrial volume, global longitudinal strain, pulse wave velocity are measured using Cardiac MRI at 12 months of treatment 3. Marker of vitamin K status is measured using dp-ucMGP levels, Elastin degradation products (EDPs) at 12 months of treatment 4. Vascular health is measured using office (brachial) blood pressure, electrocardiogram (ECG), augmentation index measured by applanation tonometry at the radial artery at 12 months of treatment 5. Coronary and aortic calcification is measured using cardiac CT scan at 12 months of treatment 6. Bone metabolism and turnover measured using calcium, phosphate, parathyroid hormone, fibroblast growth factor-23 (FGF-23), 25-hydroxyvitamin D, 1,25-hydroxyvitamin D, osteocalcin, fetuin, bone morphogenetic protein (BMP), Tartrate resistant acid phosphatase-5b (TRAP-5b) at 12 months of treatment 7. Cardiovascular markers are measured using high-sensitivity troponin and brain natriuretic peptide at 12 months of treatment 8. Endothelial function is measured using Asymmetric Dimethylarginine (ADMA) at 12 months of treatment 9. Dietary vitamin K content is estimated at baseline using 28-day food diary 10. Transplant function is measured using blood tests for urea and electrolytes at 12 months of treatment 11. Proteinuria is measured using urinary protein to creatinine ratio at 12 months of treatment 12. Quality of life is measured using the EQ-5D at 12 months of treatment

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Countries

United Kingdom

Contacts

Public ContactJennifer Lees

jennifer.lees@glasgow.ac.uk+44 141 330 2409

Outcome results

None listed