To study the effect of vitamin K supplementation on calcification propensity and vitamin K status in RTRs with vitamin K deficiency.
ID
Source
Brief title
Condition
- Vitamin related disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is change from baseline to end of intervention (12 weeks) in
serum calcification propensity.
Secondary outcome
Secondary endpoints include change from baseline to end of intervention (12
weeks) in parameters of vitamin K status (e.g., dp-ucMGP) and vascular
stiffness (i.e., pulse wave velocity).
Background summary
Vascular vitamin K deficiency is prevalent among renal transplant recipients
(RTRs) and is associated with an increased risk of cardiovascular disease.
Restoring vitamin K status in RTRs is postulated to be associated with
improvement of calcification propensity.
Study 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).
Intervention
Capsules containing the dietary supplement vitamin K2 menaquinon-7 (2x180 *g;
360 *g/day) or placebo.
Study burden and risks
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.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004906-88-NL |
| CCMO | NL69395.042.20 |
| Other | Trial NL7687 |