NCT04477811

Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients

Comparative Study Evaluating the Effect of the Administration of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.

Detailed description

Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease . It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation . Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries. it is Prospective, Randomized,Placebo Controlled Study

Conditions

• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
DRUG	Vitamin K1	vitamin k1 tablets
DRUG	Vitamin k2	vitamin k2 45 ug tablets twice daily
OTHER	placebo	placebo tablets

Timeline

• Start date: 2020-07-25
• Primary completion: 2020-11-01
• Completion: 2021-01-01
• First posted: 2020-07-20
• Last updated: 2021-07-21

Locations

1 site across 1 country: Egypt