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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin k1 | Active Comparator | vitamin k1 will be given 10 mg thrice a week for 3 months |
|
| vitamin k2 | Active Comparator | vitamin k2 (menaquinone) will be given 90 ug per day orally |
|
| placebo | Placebo Comparator | placebo will be given daily per oral for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K1 | Drug | vitamin k1 tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in serum level of Uncarboxylated MGP | Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification | change between baseline and after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| parathyroid hormone | measuring change in serum PTH | change between baseline and after 3 months |
| serum calcium level | measuring the change in serum calcium level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sarah fahmy | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams University | Cairo | 02 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24533939 | Background | Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. doi: 10.2174/1381612820666140212194926. | |
| 24212088 | Background | McCabe KM, Adams MA, Holden RM. Vitamin K status in chronic kidney disease. Nutrients. 2013 Nov 7;5(11):4390-8. doi: 10.3390/nu5114390. |
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| ID | Term |
|---|---|
| D010837 | Vitamin K 1 |
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Vitamin k2 | Drug | vitamin k2 45 ug tablets twice daily |
|
|
| placebo | Other | placebo tablets |
|
| change between baseline and after 3 months |
| serum phosphate level | measuring the change in phosphate level | change between baseline and after 3 months |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |