Cardiovascular DiseasesNCT03311321
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
A study testing Vitamin K2 (menaquinone-7; 360-mcg/d) in people with Cardiovascular Diseases and Chronic Kidney Disease Stage 3, run by Augusta University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Diseases, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4
- What is being tested?
- Vitamin K2 (menaquinone-7; 360-mcg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30901
About this study
Official title: Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
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
- Being tested
- Vitamin K2 (menaquinone-7; 360-mcg/d), Placebo-Control
- Keywords
- Arterial Stiffness, Endothelial Function, Vitamin K
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic, Vitamin K Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2 (menaquinone-7; 360-mcg/d)Dietary supplement
four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Placebo-ControlDietary supplement
four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control | Placebo comparator | 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. Receives: Dietary Supplement: Placebo-Control |
| Vitamin K2 (360-mcg/d) | Experimental | The experimental group will take four 90-mcg of vitamin K2 (menaquinone-7; 360-mcg) softgel capsules every day for 8 weeks. Receives: Dietary Supplement: Vitamin K2 (menaquinone-7; 360-mcg/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation (FMD)
The FMD test is non-invasive assessment of vascular endothelial function.
Measured: Change from baseline to 8 weeks
Pulse Wave Velocity (PWV)
The PWV test is a non-invasive test of arterial stiffness.
Measured: Change from baseline to 8 weeks
Secondary outcomes (1)
Prothrombin Time
The prothrombin time test is a measurement of clotting time.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start13 Sep 2017
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Pollock, Augusta University
- Investigators
- Norman K Pollock, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311321
- Sponsor's protocol ID
- 683534
- Status last verified
- Nov 2019
- First submitted
- 9 Oct 2017
- Last updated
- 20 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29635270
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)
- ClinicalTrials.gov ID
- NCT03311321
- Acronym / sponsor ID
- 683534
- Conditions
- Cardiovascular Diseases, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5, Vitamin K Deficiency, Hemodialysis
- Keywords
- Arterial Stiffness, Endothelial Function, Vitamin K
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control | Placebo comparator | Dietary Supplement: Placebo-ControlThe 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) | Experimental | Dietary Supplement: Vitamin K2 (menaquinone-7; 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2 (menaquinone-7; 360-mcg/d)four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks | Dietary supplement | Vitamin K2 (360-mcg/d) |
| Placebo-Controlfour placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7) | Dietary supplement | Placebo-Control |
Primary outcome
Flow-Mediated Dilation (FMD)
Time frame: Change from baseline to 8 weeks
The FMD test is non-invasive assessment of vascular endothelial function.
Pulse Wave Velocity (PWV)
Time frame: Change from baseline to 8 weeks
The PWV test is a non-invasive test of arterial stiffness.
1 secondary outcome
Prothrombin Time
Time frame: Change from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 29635270Fain 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.
- Principal Investigator - Faculty ProfileLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman K Pollock, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 (menaquinone-7; 360-mcg/d) in people with Cardiovascular Diseases and Chronic Kidney Disease Stage 3, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norman K Pollock, PhD (706-721-4524, npollock@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-Mediated Dilation (FMD) (time frame: Change from baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.