Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145492
• Other study ID #: 12
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Vascular Calcification

Intervention

Drug:
• Vitamin K2
Patients will take 90 ug of vitamin K2
• Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
• Vitamin K2 and Cholecalciferol
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D

Locations

Country	Name	City	State
Egypt	Radwa Maher El Borolossy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncarboxylated MGP	Measuring serum level of Uncarboxylated MGP as a marker for calcification	4 months
Primary	Uncarboxylated osteocalcin	Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification	4 months