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

Sponsor

Augusta University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03311321

Collaborator

(none)

Enrollment

Location

Arms

51.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Chronic Kidney Disease Stage 3 Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 Vitamin K Deficiency Hemodialysis	Dietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d) Dietary Supplement: Placebo-Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 13, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: 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.

Dietary Supplement: Placebo-Control

four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)

Experimental: Vitamin K2 (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.

Dietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d)

four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks

Outcome Measures

Primary Outcome Measures

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

Prothrombin Time [Change from baseline to 8 weeks]
The prothrombin time test is a measurement of clotting time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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