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

Rogier Caluwe

Status and phase: Completed; Phase 3

Conditions: Vascular Calcification

Treatments: Dietary Supplement: Vitamin K2 supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01675206

2010/066

Details and patient eligibility

About

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

Full description

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

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 3 patient groups

360 µg Vit K2

Active Comparator group

Description:

Administration of 360 µg of Vitamin K2 thrice weekly

Treatment:

Dietary Supplement: Vitamin K2 supplementation

720 µg Vit K2

Active Comparator group

Description:

Administration of 720 µg of Vitamin K2 thrice weekly

Treatment:

Dietary Supplement: Vitamin K2 supplementation

1080 µg Vit K2

Active Comparator group

Description:

Administration of 1080 µg of Vitamin K2 thrice weekly

Treatment:

Dietary Supplement: Vitamin K2 supplementation