Arterial Stiffness, Vitamin K2 Deficiency
Conditions
Brief summary
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.
Interventions
DIETARY_SUPPLEMENTVitamin K2 (MK7)
Sponsors
Omicron Pharmaceuticals
Lebanese American University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Functional renal graft * Stable renal function for at least 3 months prior to enrollment
Exclusion criteria
* History of thrombotic events * Diagnosed coagulopathy * Cardiovascular event in the past month prior to enrollment * Current or planned pregnancy * Lactation * Soy allergy * Concomitant or recent (past 6 months) use of supplements that contain vitamin K * Warfarin treatment * Known intestinal malabsorption or hypomotility syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | 8 weeks |
| Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | 8 weeks |
| Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks | 8 weeks |
Countries
Lebanon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin K2 (MK7) Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Vitamin K2 (MK7) | — |
|---|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 10.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Lebanon | 60 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
| Transplantation duration | 15.9 years STANDARD_DEVIATION 6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 12 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin K2 (MK7) | Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks | -1.4 m/s | Standard Error 0.2 |
Secondary
Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time frame: 8 weeks
Secondary
Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks
Time frame: 8 weeks
Secondary
Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time frame: 8 weeks