Clinical trial NCT03311321: Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
Official title: Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Chronic Kidney Disease Stage 3
Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Vitamin K Deficiency
Hemodialysis
Keywords: Arterial Stiffness
Endothelial Function
Vitamin K
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Flow-Mediated Dilation (FMD)
timeFrame: Change from baseline to 8 weeks
measure: Pulse Wave Velocity (PWV)
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Prothrombin Time
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Norman K Pollock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fain ME, Kapuku GK, Paulson WD, Williams CF, Raed A, Dong Y, Knapen MHJ, Vermeer C, Pollock NK. Inactive Matrix Gla Protein, Arterial Stiffness, and Endothelial Function in African American Hemodialysis Patients. Am J Hypertens. 2018 May 7;31(6):735-741. doi: 10.1093/ajh/hpy049.