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Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

A

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

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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