Placebo-gecontroleerde dubbelblinde gerandomiseerde gecontroleerde studie naar vitamine K-suppletie op vasculaire calcificatie-neiging bij niertransplantatiepatiënten met vitamine K-deficiëntie

Placebo-controlled double-blind randomized controlled trial investigating vitamin K supplementation on vascular calcification propensity in vitamin K deficient renal transplant recipients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23704

Enrollment

Registered

2019-02-27

Start date

2020-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Renal transplant recipients with vitamin K deficiency

Interventions

Capsules containing vitamin K2 menaquinon-7 (2x180 µg

360 µg/day) or placebo.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint is change from baseline in serum calcification propensity at 12 weeks following intervention.	—

Secondary

Measure	Time frame
Secondary endpoints includes change from baseline in parameters of vitamin K status (e.g., dp-ucMGP) and vascular stiffness (i.e., pulse wave velocity).	—

Contacts

Public ContactCharlotte te Velde - Keyzer

UMCG

c.a.keyzer@umcg.nl0625646520

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)