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Completed

NCT Number: NCT02517580

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

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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Key information

Conditions

Arterial Stiffness Vitamin K2 Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lebanese American University Medical Center - Rizk Hospital

El Achrafiyé, Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K2 (MK7)

Dietary Supplement

Other names: MenaQ7

Primary outcomes

  1. Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lebanese American University

Other

Collaborators

  • Omicron Pharmaceuticals

Registry information

Official study title

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

Acronym: KING

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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