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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01675206
Other study ID # 2010/066
Secondary ID
Status Completed
Phase Phase 3
First received August 22, 2012
Last updated August 25, 2012
Start date May 2011
Est. completion date April 2012

Study information

Verified date August 2012
Source Onze Lieve Vrouw Hospital
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date April 2012
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin K2 supplementation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rogier Caluwe

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP 8 weeks No
Secondary Assessment of adverse reactions associated with Vitamin K2 intake 8 weeks Yes
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