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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Drug: Vitamin K1
* Drug: Vitamin k2
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes aged between 18-75 years Patients on HD greater than 3 months at least. Stable clinical condition (no hospitalization in the previous 3 months) Exclusion Criteria: Hypersensitivity to vitamin k Participant in an another clinical trial within the past 4 weeks. Judged to be unsuitable as a subject by the attending physician. Patients taking warfarin Patients with known intestinal malabsorption Patients with hypercoagulable state

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin k1<br>vitamin k1 will be given 10 mg thrice a week for 3 months | Drug: Vitamin K1<br>* vitamin k1 tablets<br>* Other names: Phylloquinone;|
| Active Comparator: vitamin k2<br>vitamin k2 (menaquinone) will be given 90 ug per day orally | Drug: Vitamin k2<br>* vitamin k2 45 ug tablets twice daily<br>* Other names: menaquinone;|
| Placebo Comparator: placebo<br>placebo will be given daily per oral for 3 months | Other: placebo<br>* placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | change between baseline and after 3 months | 
| serum phosphate level | measuring the change in phosphate level | change between baseline and after 3 months |