Supplementation of vitamin K among RTRs is postulated to be associated with restoring calcification propensity.
ID
Bron
Verkorte titel
Aandoening
Renal transplant recipients with vitamin K deficiency
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is change from baseline in serum calcification propensity at 12 weeks following intervention.
Achtergrond van het onderzoek
Rationale: Vascular vitamin K deficiency is prevalent among renal transplant recipients (RTRs) and is associated with an increased risk of cardiovascular disease. Supplementation of vitamin K among RTRs is postulated to be associated with improvement of calcification propensity.
Objective: To study the effect of vitamin K supplementation on calcification propensity and vitamin K status in RTRs with vitamin K deficiency.
Study design: Investigator-initiated, mono-center, double-blind, placebo-controlled randomized clinical trial (12 weeks, 2 arms: vitamin K2 MK-7 vs. placebo).
Study population: Outpatients (age ≥ 18 years), renal transplant recipients with vitamin K deficiency (dp-ucMGP > 500 pmol/L) who do not have an indication for vitamin K antagonists or direct oral anticoagulants treatment.
Intervention: Capsules containing vitamin K2 menaquinon-7 (2x180 μg; 360 μg/day) or placebo.
Main study parameters/endpoints: Primary endpoint is change from baseline in serum calcification propensity at 12 weeks following intervention. Secondary endpoints includes change from baseline in parameters of vitamin K status (e.g., dp-ucMGP) and vascular stiffness (i.e., pulse wave velocity).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study includes two study visits which include blood sampling, 24-hour urine collection, and measurements of blood pressure and pulse wave velocity. These procedures are all routine clinical measurements and safe. Patients may experience a pill-burden (2 capsules/day). Multiple clinical studies indicate that vitamin K2 supplementation in the proposed doses is safe and does not cause hypercoagulation. Furthermore, WHO has set no upper tolerance level for vitamin K intake.
Doel van het onderzoek
Supplementation of vitamin K among RTRs is postulated to be associated with restoring calcification propensity.
Onderzoeksopzet
V1 (baseline) and V2 (after 12 weeks)
Onderzoeksproduct en/of interventie
Capsules containing vitamin K2 menaquinon-7 (2x180 μg; 360 μg/day) or placebo.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7687 |
| Ander register | METC UMCG : METc 2019/249 |