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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    60
  • sponsor
    Augusta University
Updated on 23 January 2021
cardiovascular disease
chronic disease
renal failure
nephropathy
vitamins
vascular calcification

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.

Details
Condition Vitamin K Deficiency, Hemodialysis, Cardiovascular Disease, Vitamin Deficiency, Stage 5 Chronic Kidney Disease, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, CKD Stage 5, CKD Stage 3, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment Placebo-Control, Vitamin K2 (menaquinone-7; 360-mcg/d)
Clinical Study IdentifierNCT03311321
SponsorAugusta University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Kidney Disease Stage 3 or Chronic Kidney Disease Stage 5 or Hemodialysis or Chronic Kidney Disease Stage 4 or Cardiovascular Disease or Vitami...?
Do you have any of these conditions: CKD Stage 5 or Chronic Kidney Disease Stage 4 or cardiovascular disorders or Hemodialysis or cardiovascular disease (cvd) or Chronic Kidney Disease St...?
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
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