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

Augusta University

Status: Unknown

Conditions: Hemodialysis; Vitamin K Deficiency; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Cardiovascular Diseases; Chronic Kidney Disease Stage 5

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03311321

683534

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo-Control

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo-Control

Vitamin K2 (360-mcg/d)

Experimental group

Description:

The experimental group will take four 90-mcg of vitamin K2 (menaquinone-7; 360-mcg) softgel capsules every day for 8 weeks.

Treatment:

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