Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)

Arterial Stiffness Clinical Trial

— KING  

Official title:

Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517580
• Other study ID #: MK7-002
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2015
• Last updated: August 2, 2017
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Lebanese American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Vitamin K2 Deficiency

Intervention

Dietary Supplement:
• Vitamin K2 (MK7)

Locations

Country	Name	City	State
Lebanon	Lebanese American University Medical Center - Rizk Hospital	Ashrafieh	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Lebanese American University	Omicron Pharmaceuticals

Country where clinical trial is conducted

Lebanon, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks		8 weeks
Secondary	Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks		8 weeks
Secondary	Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks		8 weeks
Secondary	Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks		8 weeks