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Completed

NCT Number: NCT01675206

Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients

This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥18 year
  • signed informed consent
  • end stage renal disease treated with chronic hemodialysis at least three times a week

Exclusion criteria

  • coumarin treatment
  • known intestinal malabsorption
  • inability to take oral medication
  • medical conditions with a considerable probability for death within 2 months

Treatment and study plan

Vitamin K2 supplementation

Dietary Supplement

Primary outcomes

  1. percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation

    Time frame: 8 weeks

    this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP

Secondary outcomes

  1. Assessment of adverse reactions associated with Vitamin K2 intake

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Rogier Caluwe

Other

Registry information

Official study title

Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 29, 2012
Registry last updated
Aug 29, 2012

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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