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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Notify MeKey information
Conditions
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
Primary outcomes
-
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
-
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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