The life span of adults with end-stage renal disease is reduced, and cardiovascular disease (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD). Vascular calcification is a key process in the development of atherosclerotic and arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD events in HD patients. Recently, there has been growing interest in the vitamin K-dependent matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular calcification, possibly by means of improving vascular function. The relationship between MGP and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this 8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether daily vitamin K supplementation can favorably alter measurements of endothelial function and arterial stiffness in HD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)
Augusta University
Augusta, Georgia, United States
RECRUITINGFlow-Mediated Dilation (FMD)
The FMD test is non-invasive assessment of vascular endothelial function.
Time frame: Change from baseline to 8 weeks
Pulse Wave Velocity (PWV)
The PWV test is a non-invasive test of arterial stiffness.
Time frame: Change from baseline to 8 weeks
Prothrombin Time
The prothrombin time test is a measurement of clotting time.
Time frame: Change from baseline to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.