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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- Prothrombin Time [ Time Frame: Change from baseline to 8 weeks ]The prothrombin time test is a measurement of clotting time.
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
|Contact: Norman K Pollock, PhDemail@example.com|
|Contact: Celestine Williams, MSfirstname.lastname@example.org|
|United States, Georgia|
|Augusta, Georgia, United States, 30901|
|Principal Investigator:||Norman K Pollock, PhD||Augusta University|