Phase 2
N=60
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
Arterial Stiffness · Vitamin K2 Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02517580 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks — -1.4 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin K2 (MK7) (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lebanese American University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks |
-1.4 | — |
| SECONDARY Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks |
— | — |
| SECONDARY Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks |
— | — |
| SECONDARY Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02517580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.