Trial | NCT01675206  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    menaquinone ...

  • Study Participants

    165
This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.
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
Study Started
May 31
2011
Primary Completion
Sep 30
2011
Study Completion
Apr 30
2012
Last Update
Aug 29
2012
Estimate

Dietary Supplement Vitamin K2 supplementation

360 µg Vit K2 Active Comparator

Administration of 360 µg of Vitamin K2 thrice weekly

720 µg Vit K2 Active Comparator

Administration of 720 µg of Vitamin K2 thrice weekly

1080 µg Vit K2 Active Comparator

Administration of 1080 µg of Vitamin K2 thrice weekly

Criteria 

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
No Results Posted