Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
- Conditions
- Chronic Kidney Disease Stage 5Vitamin K DeficiencyChronic Kidney Disease Stage 3HemodialysisCardiovascular DiseasesChronic Kidney Disease Stage 4
- Interventions
- Dietary Supplement: Placebo-ControlDietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d)
- Registration Number
- NCT03311321
- Lead Sponsor
- Augusta University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Chronic Kidney Disease Stages 3 to 5
- Receiving hemodialysis treatment for at least 3 months
- Subject understands the study protocol and agrees to comply with it
- Informed consent documents signed by subject
- Using vitamin supplements containing vitamin K
- History of metabolic gastrointestinal diseases
- Subjects presenting chronic degenerative and/or inflammatory diseases
- Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
- Subjects receiving corticosteroid
- Use of anticoagulants
- History of soy allergy
- Have an unstable medical condition, such as having a life expectancy of less than 6 months in the judgment of the investigator
- Known sensitivity, intolerance, or other adverse response to study drugs which would prevent compliance with study medication
- Subjects who have participated in a clinical study more recently than one month before the current study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo-Control Placebo-Control The placebo-control group will take four placebo softgel capsules (similar in taste and appearance to the vitamin K2 supplements) every day for 8 weeks. Vitamin K2 (360-mcg/d) Vitamin K2 (menaquinone-7; 360-mcg/d) The experimental group will take four 90-mcg of vitamin K2 (menaquinone-7; 360-mcg) softgel capsules every day for 8 weeks.
- Primary Outcome Measures
Name Time Method Flow-Mediated Dilation (FMD) Change from baseline to 8 weeks The FMD test is non-invasive assessment of vascular endothelial function.
Pulse Wave Velocity (PWV) Change from baseline to 8 weeks The PWV test is a non-invasive test of arterial stiffness.
- Secondary Outcome Measures
Name Time Method Prothrombin Time Change from baseline to 8 weeks The prothrombin time test is a measurement of clotting time.
Trial Locations
- Locations (1)
Augusta University
🇺🇸Augusta, Georgia, United States