Trials / Completed
CompletedNCT02870829
Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- National University Health System, Singapore · Academic / Other
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients. This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.
Conditions
- Vascular Calcification
- Systemic and Arterial Stiffness
- Complication of Hemodialysis
- Deficiency of Vitamin K2
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | menaquinone-7 | Oral supplement given post dialysis 3x/week |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
- First posted
- 2016-08-17
- Last updated
- 2023-01-17
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT02870829. Inclusion in this directory is not an endorsement.