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Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?

NCT02876354 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-09-20

No results posted yet for this study

Summary

Vitamin K2 deficiency has been shown to be profound in hemodialysis patients. It is reflected by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and seems to be correlated with vascular calcifications. Vascular calcifications can be assessed using the AC24 score on a lateral abdominal X-ray.

The aim of this study is to assess first the rate of decrease of dp-ucMGP in a hemodialysis cohort after supplementation with vitamin K2 and the correlation between this rate of decrease and the Aortic Calcification Severity (AC24) score. The factors associated with high levels of dp-ucMGP will be analyzed as well.

Conditions

  • Vascular Calcifications

Interventions

DRUG

Menaquinone

Patients on hemodialysis will be supplemented by 360 μg /d of menaquinone for 4 weeks. At baseline they will have a lateral abdominal X-Ray and dosage of dp-ucMGP. At the end of the study patients will have a second measurement of dp-ucMGP levels.

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Mabel Aoun, MD · Université Saint-Joseph, Beirut, Lebanon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Lebanon

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 NCT02876354 on ClinicalTrials.gov