Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients

Cardiovascular Diseases Clinical Trial

Official title:

Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311321
• Other study ID #: 683534
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2019
• Source: Augusta University
• Contact: Norman K Pollock, PhD
• Phone: 706-721-4524
• Email: npollock[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease Stage 3
• Chronic Kidney Disease Stage 4
• Chronic Kidney Disease Stage 5
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin K Deficiency

Intervention

Dietary Supplement:
• Vitamin K2 (menaquinone-7; 360-mcg/d)
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
• Placebo-Control
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-Mediated Dilation (FMD)	The FMD test is non-invasive assessment of vascular endothelial function.	Change from baseline to 8 weeks
Primary	Pulse Wave Velocity (PWV)	The PWV test is a non-invasive test of arterial stiffness.	Change from baseline to 8 weeks
Secondary	Prothrombin Time	The prothrombin time test is a measurement of clotting time.	Change from baseline to 8 weeks

External Links

•   Principal Investigator - Faculty Profile