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

NCT02876354 | Completed Phase 4 DMC

• 1 other identifier: SGH001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemodialysis; Vitamin k2; Vascular calcifications

Outcome Measures

Primary Outcomes (1)

• Rate of decrease of dp-ucMGP after daily supplementation with menaquinone

  We will analyze whether the percentage of decrease of dp-ucMGP in our Middle-Eastern country following vitamin k2 supplementation is similar to that reported in the previous trials in Europe.

  Baseline-Four weeks

Study Arms (1)

Menaquinone 360

EXPERIMENTAL

All patients in the study will be assigned to receive menaquinone 360 μg /d for 4 weeks.

Drug: Menaquinone

Interventions

Menaquinone DRUG

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.

Also known as: Vitamin k2

Menaquinone 360

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on chronic hemodialysis in our center older than 18 years old who sign the informed consent.

You may not qualify if:

• Patients who are not eligible for a discontinuation of vitamin k antagonists

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Georges Hospital

Ajaltoun, Keserwan, Lebanon

Location

Related Publications (1)

• Aoun M, Makki M, Azar H, Matta H, Chelala DN. High Dephosphorylated-Uncarboxylated MGP in Hemodialysis patients: risk factors and response to vitamin K2, A pre-post intervention clinical trial. BMC Nephrol. 2017 Jun 7;18(1):191. doi: 10.1186/s12882-017-0609-3.

  PMID: 28592319 DERIVED

MeSH Terms

Conditions

Vascular Calcification

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Mabel Aoun, MD

  Université Saint-Joseph, Beirut, Lebanon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Nephrology, Saint-Georges Hospital Ajaltoun

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 23, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)