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

Phase 2

Completed

• Conditions: Arterial Stiffness; Vitamin K2 Deficiency
• Interventions: Dietary Supplement: Vitamin K2 (MK7)

• Registration Number: NCT02517580
• Lead Sponsor: Lebanese American University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-08
• Results First Submitted: 2017-08-02
• Results First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Results First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Functional renal graft
• Stable renal function for at least 3 months prior to enrollment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin K2 (MK7)	Vitamin K2 (MK7)	Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
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
Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks	8 weeks

Trial Locations

Locations (1)

Lebanese American University Medical Center - Rizk Hospital; 🇱🇧 Ashrafieh, Beirut, Lebanon