Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

Phase 2

• Conditions: End Stage Renal Disease
• Interventions: Drug: Cholecalciferol (inactive vitamin D); Drug: Vitamin K2; Drug: Vitamin K2 and Cholecalciferol

• Registration Number: NCT04145492
• Lead Sponsor: Ain Shams University

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol group	Cholecalciferol (inactive vitamin D)	15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
Vitamin K2 and Cholecalciferol group	Cholecalciferol (inactive vitamin D)	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.
Vitamin K2 and Cholecalciferol group	Vitamin K2 and Cholecalciferol	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.
Vitamin K2 group	Vitamin K2	15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.

Primary Outcome Measures

Name	Time	Method
Uncarboxylated MGP	4 months	Measuring serum level of Uncarboxylated MGP as a marker for calcification
Uncarboxylated osteocalcin	4 months	Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification

Trial Locations

Locations (1)

Radwa Maher El Borolossy; 🇪🇬 Cairo, Egypt