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Vitamin K2 and Inactive Vitamin D in Pediatric Hemodialysis Patients
NCT04145492Phase 3
Key facts
- Status
- Unknown
- Start
- Sep 2019
- Primary completion
- Jan 2020
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- menaquinonevitamin d
- Conditions
- Vascular calcification
01
Overview
Phase 3, randomised trial of menaquinone and vitamin d in Vascular calcification (4 arms), sponsored by Ain Shams University. Primary endpoints: Uncarboxylated Matrix Gla Protein at 4 months and Uncarboxylated osteocalcin at 4 months. Status: unknown.
02
Design
4 arms- Study design
- Randomized
Vitamin K2 group
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
Cholecalciferol group
15 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
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.
Control group
15 patients will take the standard therapy.
03
Who it enrols
Pediatric patients aged 6-18 on regular hemodialysis for at least 3 months, excluding those with life expectancy < 3 months, taking warfarin, or with intestinal malabsorption.
04
Endpoints
Primary
Uncarboxylated Matrix Gla Protein
Uncarboxylated osteocalcin
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