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

Lebanese American University

Status and phase: Completed; Phase 2

Conditions: Vitamin K2 Deficiency; Arterial Stiffness

Treatments: Dietary Supplement: Vitamin K2 (MK7)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02517580

MK7-002

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Vitamin K2 (MK7)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin K2 (MK7)