Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Sep 2017
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2017
CompletedFirst Submitted
Initial submission to the registry
October 9, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedNovember 20, 2019
November 1, 2019
4.2 years
October 9, 2017
November 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Flow-Mediated Dilation (FMD)
The FMD test is non-invasive assessment of vascular endothelial function.
Change from baseline to 8 weeks
Pulse Wave Velocity (PWV)
The PWV test is a non-invasive test of arterial stiffness.
Change from baseline to 8 weeks
Secondary Outcomes (1)
Prothrombin Time
Change from baseline to 8 weeks
Study Arms (2)
Placebo-Control
PLACEBO COMPARATORThe placebo-control group will take four placebo softgel capsules (similar in taste and appearance to the vitamin K2 supplements) every day for 8 weeks.
Vitamin K2 (360-mcg/d)
EXPERIMENTALThe experimental group will take four 90-mcg of vitamin K2 (menaquinone-7; 360-mcg) softgel capsules every day for 8 weeks.
Interventions
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Augusta University
Augusta, Georgia, 30901, United States
Related Publications (1)
Fain ME, Kapuku GK, Paulson WD, Williams CF, Raed A, Dong Y, Knapen MHJ, Vermeer C, Pollock NK. Inactive Matrix Gla Protein, Arterial Stiffness, and Endothelial Function in African American Hemodialysis Patients. Am J Hypertens. 2018 May 7;31(6):735-741. doi: 10.1093/ajh/hpy049.
PMID: 29635270BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman K Pollock, PhD
Augusta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Medicine
Study Record Dates
First Submitted
October 9, 2017
First Posted
October 17, 2017
Study Start
September 13, 2017
Primary Completion
December 1, 2021
Study Completion
December 30, 2021
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data will become available on June 1, 2019 for approximately 12 months.
- Access Criteria
- The principal investigator will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
1. Approximate date of when the data will be shared? 2019-06-01 2. Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator. 3. Please explain any limits to data sharing that might be required. Even though the final research data will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the principal investigator will make the data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.