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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03311321
Other study ID # 683534
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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