Effect of Menaquinone-7 Supplementation on Arterial Stiffness in Chronic Hemodialysis patients: A Multicenter Randomized Controlled Trial
Phase 3
Completed
- Conditions
- Change of cfPWV and progression of arterial stiffness after 12 and 24 weeks of oral MK-7 supplementation, Change of biochemistry parameters, vascular and bone turnover markers in blood after 12 and 24 weeks of oral MK-7 treatment, Incidence of side effects, thrombotic events and death from MK-7 supplementMenaquinone-7, Arterial stiffness, Carotid-femoral pulse wave velocity, Chronic hemodialysis
- Registration Number
- TCTR20230217001
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
Age equal or more than 18 years at screening
Undergoing maintenance HD at least 2 times a week for more than 1 month prior to screening and compliance with HD treatments
cfPWV measurement equal or more than 10 m/s at screening visit
Exclusion Criteria
Pregnancy and breastfeeding
Receiving vitamin K antagonist or warfarin
Receiving and/or history of vitamin K supplementation in 3 months before screening
History of percutaneous coronary intervention and/or coronary artery bypass grafting
Patients with conditions that were unable to assess cfPWV including deformity of peripheral limbs, amputation, and severe peripheral vascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cPWV change 24 weeks Carotid-femoral pulse wave velocity
- Secondary Outcome Measures
Name Time Method Change in blood sugar, HbA1C 24 weeks laboratory chemistry,Change in cholesterol 24 weeks laboratory chemistry,Change in iPTH, vitamin D (25-OH vitamin D) 24 weeks laboratory chemistry,Change in serum calcium, phosphate and albumin 24 weeks laboratory chemistry,Aortic calcification score 24 weeks abdominal lateral x-ray