Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Vitamin K2
* Drug: Cholecalciferol (inactive vitamin D)
* Drug: Vitamin K2 and Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin K2 group<br>15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months. | Drug: Vitamin K2<br>* Patients will take 90 ug of vitamin K2<br>* Other names: Group 1;|
| Active Comparator: Cholecalciferol group<br>15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months. | Drug: Cholecalciferol (inactive vitamin D)<br>* Patients will take 10 ug of vitamin inactive vitamin D<br>* Other names: Group 2;|
| Active Comparator: Vitamin K2 and Cholecalciferol group<br>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. | Drug: Cholecalciferol (inactive vitamin D)<br>* Patients will take 10 ug of vitamin inactive vitamin D<br>* Other names: Group 2;Drug: Vitamin K2 and Cholecalciferol<br>* Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D<br>* Other names: Group 3;|
| No Intervention: Control group<br>15 patients will take the standard therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncarboxylated MGP | Measuring serum level of Uncarboxylated MGP as a marker for calcification | 4 months | 
| Uncarboxylated osteocalcin | Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis and Vitamin K2