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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04145492

Enrollment

Registered

2019-10-30

Start date

2019-09-01

Completion date

2020-02-01

Last updated

2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Hemodialysis and Vitamin K2

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.

Interventions

DRUGVitamin K2

Patients will take 90 ug of vitamin K2

DRUGCholecalciferol (inactive vitamin D)

Patients will take 10 ug of vitamin inactive vitamin D

DRUGVitamin K2 and Cholecalciferol

Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026