Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

Ain Shams University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Vitamin K2; Drug: Vitamin K2 and Cholecalciferol; Drug: Cholecalciferol (inactive vitamin D)

Study type: Interventional

Funder types: Other

Identifiers

NCT04145492

12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Vitamin K2 group

Active Comparator group

Description:

15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.

Treatment:

Drug: Vitamin K2

Cholecalciferol group

Active Comparator group

Description:

15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.

Treatment:

Drug: Cholecalciferol (inactive vitamin D)

Vitamin K2 and Cholecalciferol group

Active Comparator group

Description:

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.

Treatment:

Drug: Cholecalciferol (inactive vitamin D)

Drug: Vitamin K2 and Cholecalciferol

Control group

No Intervention group

Description:

15 patients will take the standard therapy.