Recruiting

Vitamin K

Sponsor:

Augusta University

Code:

NCT03311321

Conditions

Cardiovascular Diseases

Chronic Kidney Disease Stage 3

Chronic Kidney Disease Stage 4

Chronic Kidney Disease Stage 5

Vitamin K Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

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

Placebo-Control

Study Details

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.

Conditions

Cardiovascular Diseases

Chronic Kidney Disease Stage 3

Chronic Kidney Disease Stage 4

Chronic Kidney Disease Stage 5

Vitamin K Deficiency

Study ID

NCT03311321

Start date

Sep 13, 2017

Status verified date

Nov, 2019

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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)

Primary outcome measure

  • Flow-Mediated Dilation (FMD) [ Time Frame: Change from baseline to 8 weeks ]
  • Pulse Wave Velocity (PWV) [ Time Frame: Change from baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30901

More Information

Sponsor

Augusta University

Last update posted

Nov 20, 2019

Last verified

Nov, 2019

Keywords

  • Arterial Stiffness
  • Endothelial Function
  • Vitamin K

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Augusta University on 2019-11-20.