MedTrace Logo

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

NCT03311321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-20

No results posted yet for this study

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
  • Hemodialysis

Interventions

DIETARY_SUPPLEMENT

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

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

DIETARY_SUPPLEMENT

Placebo-Control

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

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Norman K Pollock, PhD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2021-12-01
Completion
2021-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311321 on ClinicalTrials.gov