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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedOctober 30, 2019
October 1, 2019
4 months
October 28, 2019
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
Vitamin K2 group
ACTIVE COMPARATOR15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
Cholecalciferol group
ACTIVE COMPARATOR15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
Vitamin K2 and Cholecalciferol group
ACTIVE COMPARATOR15 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.
Control group
NO INTERVENTION15 patients will take the standard therapy.
Interventions
Patients will take 10 ug of vitamin inactive vitamin D
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
Eligibility Criteria
You may qualify if:
- Patients aged 6-18 years
- Patients on hemodialysis since 3 months or longer
- Hemodialysis frequency 3 times or more weekly
You may not qualify if:
- Patients with life expectancy \< 3 months
- Patients taking warfarin
- Patients with known intestinal malabsorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radwa Maher El Borolossy
Cairo, 0000, Egypt
Related Publications (1)
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.
PMID: 34845313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of clinical pharmacy
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
September 1, 2019
Primary Completion
January 1, 2020
Study Completion
February 1, 2020
Last Updated
October 30, 2019
Record last verified: 2019-10