Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
NCT ID: NCT04145492
Last Updated: 2019-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2019-09-01
2020-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vitamin K2 group
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
Vitamin K2
Patients will take 90 ug of vitamin K2
Cholecalciferol group
15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
Vitamin K2 and Cholecalciferol group
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.
Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
Vitamin K2 and Cholecalciferol
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
Control group
15 patients will take the standard therapy.
No interventions assigned to this group
Interventions
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Vitamin K2
Patients will take 90 ug of vitamin K2
Cholecalciferol (inactive vitamin D)
Patients will take 10 ug of vitamin inactive vitamin D
Vitamin K2 and Cholecalciferol
Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients on hemodialysis since 3 months or longer
* Hemodialysis frequency 3 times or more weekly
Exclusion Criteria
* Patients taking warfarin
* Patients with known intestinal malabsorption
6 Years
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Radwa Maher Abd El Kader El Borolossy
lecturer of clinical pharmacy
Locations
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Radwa Maher El Borolossy
Cairo, , Egypt
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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12
Identifier Type: -
Identifier Source: org_study_id
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