Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

October 29, 2019 updated by: Radwa Maher Abd El Kader El Borolossy, Ain Shams University

The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries [3, 4]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 0000
        • Recruiting
        • Radwa Maher El Borolossy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients aged 6-18 years
  • Patients on hemodialysis since 3 months or longer
  • Hemodialysis frequency 3 times or more weekly

Exclusion criteria:

  • Patients with life expectancy < 3 months
  • Patients taking warfarin
  • Patients with known intestinal malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin K2 group
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
Drug: Vitamin K2
Patients will take 90 ug of vitamin K2
Other Names:
  • Group 1
Active Comparator: Cholecalciferol group
15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
Drug: Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
Other Names:
  • Group 2
Active Comparator: Vitamin K2 and Cholecalciferol group
15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months.
Drug: Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
Other Names:
  • Group 2
Drug: Vitamin K2 and Cholecalciferol
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
Other Names:
  • Group 3
No Intervention: Control group
15 patients will take the standard therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncarboxylated MGP
Time Frame: 4 months
Measuring serum level of Uncarboxylated MGP as a marker for calcification
4 months
Uncarboxylated osteocalcin
Time Frame: 4 months
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 (Israel lung Association)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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