NCT04145492

Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Vitamin K2	Patients will take 90 ug of vitamin K2
DRUG	Cholecalciferol (inactive vitamin D)	Patients will take 10 ug of vitamin inactive vitamin D
DRUG	Vitamin K2 and Cholecalciferol	Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-01-01
• Completion: 2020-02-01
• First posted: 2019-10-30
• Last updated: 2019-10-30

Locations

1 site across 1 country: Egypt