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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2021-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients

NCT02976246

Vitamin K Supplementation Endstage Renal Disease Cardiovascular Disease +1 more

COMPLETED PHASE4

Underlying Causes of Low Vitamin K Status in Hemodialysis Patients

NCT03493087

Renal Insufficiency, Chronic

COMPLETED NA

Vitamin K2 Supplementation and Vascular Calcification

NCT04539418

Renal Disease

COMPLETED PHASE4

Vitamin K Supplementation in Patients on Hemodialysis

NCT02324686

End Stage Renal Failure on Dialysis Atrial Fibrillation

COMPLETED PHASE2

Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients

NCT01528800

End-stage Kidney Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Placebo-Control

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DIETARY_SUPPLEMENT

Placebo-Control

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No