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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517580
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Omicron Pharmaceuticals
Information provided by (Responsible Party):
Sola Aoun Bahous, M.D. Ph.D., 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.

Condition or disease Intervention/treatment Phase
Arterial Stiffness Vitamin K2 Deficiency Dietary Supplement: Vitamin K2 (MK7) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population
Study Start Date : March 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

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 Name: MenaQ7




Primary Outcome Measures :
  1. Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks [ Time Frame: 8 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517580


Locations
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Lebanon
Lebanese American University Medical Center - Rizk Hospital
Ashrafieh, Beirut, Lebanon
Sponsors and Collaborators
Lebanese American University
Omicron Pharmaceuticals
Investigators
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Principal Investigator: Sola Aoun Bahous, M.D. Ph.D. Lebanese American University
Publications:
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Responsible Party: Sola Aoun Bahous, M.D. Ph.D., Associate Professor of Medicine, Division of Nephrology and Transplantation, Lebanese American University
ClinicalTrials.gov Identifier: NCT02517580    
Other Study ID Numbers: MK7-002
First Posted: August 7, 2015    Key Record Dates
Results First Posted: February 9, 2018
Last Update Posted: February 9, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Vitamin K
Vitamin K 2
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants