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Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

NCT02870829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2023-01-17

No results posted yet for this study

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

DRUG

menaquinone-7

Oral supplement given post dialysis 3x/week

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Nattopharma ASA

    collaborator INDUSTRY

  • National University Health System, Singapore

    lead OTHER

Principal Investigators

  • Sabrina Wong Peixin Haroon, MD MRCP FAMS · National University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870829 on ClinicalTrials.gov