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

Phase 2

Completed

• Conditions: End Stage Renal Disease on Dialysis
• Interventions: Other: placebo; Drug: Vitamin K1; Drug: Vitamin k2

• Registration Number: NCT04477811
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Study Start: 2020-07-25
• Primary Completion: 2020-11-01
• Study Completion: 2021-01-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo will be given daily per oral for 3 months
vitamin k1	Vitamin K1	vitamin k1 will be given 10 mg thrice a week for 3 months
vitamin k2	Vitamin k2	vitamin k2 (menaquinone) will be given 90 ug per day orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
serum calcium level	change between baseline and after 3 months	measuring the change in serum calcium level
parathyroid hormone	change between baseline and after 3 months	measuring change in serum PTH
serum phosphate level	change between baseline and after 3 months	measuring the change in phosphate level

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt