Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin K2
Cholecalciferol (inactive vitamin D)
Vitamin K2 and Cholecalciferol
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring Hemodialysis and Vitamin K2
Eligibility Criteria
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
Sites / Locations
- Radwa Maher El BorolossyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Vitamin K2 group
Cholecalciferol group
Vitamin K2 and Cholecalciferol group
Control group
Arm Description
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
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.
15 patients will take the standard therapy.
Outcomes
Primary Outcome Measures
Uncarboxylated MGP
Measuring serum level of Uncarboxylated MGP as a marker for calcification
Uncarboxylated osteocalcin
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
Secondary Outcome Measures
Full Information
NCT ID
NCT04145492
First Posted
October 28, 2019
Last Updated
October 29, 2019
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04145492
Brief Title
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
Official Title
The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis and Vitamin K2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin K2 group
Arm Type
Active Comparator
Arm Description
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
Arm Title
Cholecalciferol group
Arm Type
Active Comparator
Arm Description
15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
Arm Title
Vitamin K2 and Cholecalciferol group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
15 patients will take the standard therapy.
Intervention Type
Drug
Intervention Name(s)
Vitamin K2
Other Intervention Name(s)
Group 1
Intervention Description
Patients will take 90 ug of vitamin K2
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol (inactive vitamin D)
Other Intervention Name(s)
Group 2
Intervention Description
Patients will take 10 ug of vitamin inactive vitamin D
Intervention Type
Drug
Intervention Name(s)
Vitamin K2 and Cholecalciferol
Other Intervention Name(s)
Group 3
Intervention Description
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
Primary Outcome Measure Information:
Title
Uncarboxylated MGP
Description
Measuring serum level of Uncarboxylated MGP as a marker for calcification
Time Frame
4 months
Title
Uncarboxylated osteocalcin
Description
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Radwa Maher El Borolossy
City
Cairo
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwa Maher El Borolossy, PhD
Phone
01227052880
Email
radwa.maher14@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34845313
Citation
El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29.
Results Reference
derived
Learn more about this trial
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
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