End Stage Renal Disease on Dialysis
Conditions
Brief 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
Interventions
DRUGVitamin K1
vitamin k1 tablets
DRUGVitamin k2
vitamin k2 45 ug tablets twice daily
OTHERplacebo
placebo tablets
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Both sexes aged between 18-75 years 2. Patients on HD greater than 3 months at least. 3. Stable clinical condition (no hospitalization in the previous 3 months)
Exclusion criteria
1. Hypersensitivity to vitamin k 2. Participant in an another clinical trial within the past 4 weeks. 3. Judged to be unsuitable as a subject by the attending physician. 4. Patients taking warfarin 5. Patients with known intestinal malabsorption 6. Patients with hypercoagulable state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in serum level of Uncarboxylated MGP | change between baseline and after 3 months | Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| parathyroid hormone | change between baseline and after 3 months | measuring change in serum PTH |
| serum calcium level | change between baseline and after 3 months | measuring the change in serum calcium level |
| serum phosphate level | change between baseline and after 3 months | measuring the change in phosphate level |
Countries
Egypt
Outcome results
None listed