Cardiovascular Diseases, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5, Vitamin K Deficiency, Hemodialysis
Conditions
Keywords
Arterial Stiffness, Endothelial Function, Vitamin K
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.
Interventions
DIETARY_SUPPLEMENTVitamin K2 (menaquinone-7; 360-mcg/d)
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
DIETARY_SUPPLEMENTPlacebo-Control
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Prothrombin Time | Change from baseline to 8 weeks | The prothrombin time test is a measurement of clotting time. |
Countries
United States
Contacts
Primary ContactNorman K Pollock, PhD
Backup ContactCelestine Williams, MS
Outcome results
None listed