A Phase 2/3 interventional study of Vitamin K1 and Vitamin k2 in End Stage Renal Disease on Dialysis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
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.
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
Exclusion Criteria:
vitamin k1 will be given 10 mg thrice a week for 3 months
Drug: Vitamin K1
vitamin k2 (menaquinone) will be given 90 ug per day orally
Drug: Vitamin k2
placebo will be given daily per oral for 3 months
Other: placebo
vitamin k1 tablets
Also known as: Phylloquinone
vitamin k2 45 ug tablets twice daily
Also known as: menaquinone
placebo tablets
change in serum level of Uncarboxylated MGP
Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
Time frame: change between baseline and after 3 months
parathyroid hormone
measuring change in serum PTH
Time frame: change between baseline and after 3 months
serum calcium level
measuring the change in serum calcium level
Time frame: change between baseline and after 3 months
serum phosphate level
measuring the change in phosphate level
Time frame: change between baseline and after 3 months
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams University