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Completed

NCT Number: NCT01407601

Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP), noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).

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Key information

Conditions

CKD 5D, Hemodialysis Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KfH Dialysis Unit Aachen, Aachen, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years of age
  • minimum of 3 months of hemodialysis
  • written consent

Exclusion criteria

  • chronic or acute bowel disease
  • soy bean allergy
  • active Vitamin K Supplementation
  • oral anticoagulation with vitamin K Antagonists (coumarins)
  • systemic therapy using steroids
  • positive history for thrombosis or embolism
  • pregnancy

Treatment and study plan

daily supplementation of MK-7 over 6 weeks

Dietary Supplement

once daily intake of MK-7 prior to dialysis over 6 weeks

Primary outcomes

  1. Reduction of plasma levels of noncarboxylated MGP

    Time frame: after 6 weeks of supplementation

    Noncarboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

  2. Reduction of plasma levels of noncarboxylated osteocalcin

    Time frame: after 6 weeks of supplementation

    Noncarboxylated osteocalcin levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

  3. Reduction of plasma levels of inactive prothrombin (PIVKA-II)

    Time frame: after 6 weeks of supplementation

    PIVKA-II levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma levels at the end of the six-week treatment period will be compared to baseline levels.

Secondary outcomes

  1. increase of plasma levels of carboxylated MGP

    Time frame: after 6 weeks of supplementation

    Carboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

  2. increase of plasma levels of carboxylated osteocalcin

    Time frame: after 6 weeks of supplementation

    Carboxylated MGP levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 2, 2011
Registry last updated
Aug 2, 2011

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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