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

August 2, 2017 updated by: Sola Aoun Bahous, M.D. Ph.D., Lebanese American University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Beirut
      • Ashrafieh, Beirut, Lebanon
        • Lebanese American University Medical Center - Rizk Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin K2 (MK7)
Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
Dietary supplement: Vitamin K2 (MK7)
Other Names:
  • MenaQ7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time Frame: 8 weeks
8 weeks
Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks
Time Frame: 8 weeks
8 weeks
Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lebanese American University

Collaborators

Omicron Pharmaceuticals

Investigators

  • Principal Investigator: Sola Aoun Bahous, M.D. Ph.D., Lebanese American University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK7-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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