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

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477811
• Other study ID #: vitamin k in dialysis patients
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 25, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic
• Vascular Calcification

Intervention

Drug:
• Vitamin K1
vitamin k1 tablets
• Vitamin k2
vitamin k2 45 ug tablets twice daily

Other:
• placebo
placebo tablets

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. Review. — View Citation

Palit S, Kendrick J. Vascular calcification in chronic kidney disease: role of disordered mineral metabolism. Curr Pharm Des. 2014;20(37):5829-33. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	parathyroid hormone	measuring change in serum PTH	change between baseline and after 3 months
Secondary	serum calcium level	measuring the change in serum calcium level	change between baseline and after 3 months
Secondary	serum phosphate level	measuring the change in phosphate level	change between baseline and after 3 months