Vitamin K supplementation after renal transplantatio
- Conditions
- Vitamin K deficiency is highly prevalent among renal transplant recipients, promotes vascular calcification, and is associated with an increased risk of cardiovascular disease. Supplementation of vitamin K among renal transplant recipients is postulated to be associated with improvement of vascular calcification.Study population: Outpatients (age = 18 years), renal transplant recipients with vitamin K deficiency.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-004906-88-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Age =18 years
2. Male and female renal transplant recipients
3. Participant of TransplantLines
4. Vitamin K deficient; dp-ucMGP >500 pmol/L
5. eGFR > 20 ml/min/1.73m2
6. Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Treatment with vitamin K antagonists or direct oral anticoagulants (DOAC)
2. Atrial fibrillation or other heart rhythm disorders causing an unreliable PWV measurement
3. Known coagulopathy
4. Active malignancy; exception treated basal cell or squamous cell carcinoma
5. Current or planned pregnancy or lactation
6. Known intestinal malabsorption
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method