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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arterial Stiffness Vitamin K2 Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin K2 (MK7)

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

Group Type EXPERIMENTAL

Vitamin K2 (MK7)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin K2 (MK7)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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MenaQ7

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No