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

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ClinicalTrials.gov Identifier: NCT03311321
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Norman Pollock, Augusta University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Chronic Kidney Disease Stage 3 Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 Vitamin K Deficiency Hemodialysis Dietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d) Dietary Supplement: Placebo-Control Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin K
Drug Information available for: Menadione

Arm Intervention/treatment
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.
Dietary Supplement: Placebo-Control
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)

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.
Dietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d)
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks




Primary Outcome Measures :
  1. Flow-Mediated Dilation (FMD) [ Time Frame: Change from baseline to 8 weeks ]
    The FMD test is non-invasive assessment of vascular endothelial function.

  2. Pulse Wave Velocity (PWV) [ Time Frame: Change from baseline to 8 weeks ]
    The PWV test is a non-invasive test of arterial stiffness.


Secondary Outcome Measures :
  1. Prothrombin Time [ Time Frame: Change from baseline to 8 weeks ]
    The prothrombin time test is a measurement of clotting time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311321


Contacts
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Contact: Norman K Pollock, PhD 706-721-4524 npollock@augusta.edu
Contact: Celestine Williams, MS 706-721-8553 cewilliams@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30901
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Norman K Pollock, PhD Augusta University

Publications:
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Responsible Party: Norman Pollock, Associate Professor, Department of Population Health Sciences, Augusta University
ClinicalTrials.gov Identifier: NCT03311321     History of Changes
Other Study ID Numbers: 683534
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://www.augusta.edu/mcg/dphs/gpi/clinicalresearch.php

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norman Pollock, Augusta University:
Arterial Stiffness
Endothelial Function
Vitamin K

Additional relevant MeSH terms:
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Kidney Diseases
Cardiovascular Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vitamin K Deficiency
Urologic Diseases
Renal Insufficiency
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants