Placebo-controlled double-blind randomized controlled trial investigating vitamin K supplementation on vascular calcification propensity in vitamin K deficient renal transplant recipients
Phase 3
Withdrawn
- Conditions
- vascular calcification propensity1004763510003216
- Registration Number
- NL-OMON49950
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion 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
Exclusion Criteria
1. Treatment with vitamin K antagonists or direct oral anticoagulants (DOAC)
2. Atrial fibrillation
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is change from baseline to end of intervention (12 weeks) in<br /><br>serum calcification propensity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include change from baseline to end of intervention (12<br /><br>weeks) in parameters of vitamin K status (e.g., dp-ucMGP) and vascular<br /><br>stiffness (i.e., pulse wave velocity).</p><br>