Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
KING
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
February 9, 2018
CompletedFebruary 9, 2018
August 1, 2017
1.2 years
August 5, 2015
August 2, 2017
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
8 weeks
Secondary Outcomes (3)
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
Study Arms (1)
Vitamin K2 (MK7)
EXPERIMENTALVitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Functional renal graft
- Stable renal function for at least 3 months prior to enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lebanese American Universitylead
- Omicron Pharmaceuticalscollaborator
Study Sites (1)
Lebanese American University Medical Center - Rizk Hospital
El Achrafiyé, Beyrouth, Lebanon
Related Publications (1)
Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13.
PMID: 28756183BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sola Aoun Bahous
- Organization
- Lebanese American University
Study Officials
- PRINCIPAL INVESTIGATOR
Sola Aoun Bahous, M.D. Ph.D.
Lebanese American University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Division of Nephrology and Transplantation
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 7, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
February 9, 2018
Results First Posted
February 9, 2018
Record last verified: 2017-08