An interventional study of Vitamin K2 (menaquinone-7; 360-mcg/d) and Placebo-Control in Cardiovascular Diseases, Chronic Kidney Disease Stage 3 and Chronic Kidney Disease Stage 4, sponsored by Augusta University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by Augusta University · Not applicable, Interventional, and Prevention
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.
5,370 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Drug page: Vitamin K 2
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)
Flow-Mediated Dilation (FMD)
The FMD test is non-invasive assessment of vascular endothelial function.
Time frame: Change from baseline to 8 weeks
Pulse Wave Velocity (PWV)
The PWV test is a non-invasive test of arterial stiffness.
Time frame: Change from baseline to 8 weeks
Prothrombin Time
The prothrombin time test is a measurement of clotting time.
Time frame: Change from baseline to 8 weeks
Plan to share: Yes — Approximate date of when the data will be shared? 2019-06-01 Where will the data be made available? The de-identified data will be made available for research purposes only by contacting the principal investigator. 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Data sharing details ↗ · www.augusta.edu
Started Sep 2017 (actual). Primary completion is estimated for Dec 2021, 50 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 50 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin K 2