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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Drug: Vitamin K1; Drug: Vitamin k2; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: sarah fahmy, Ain Shams University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Calcium Metabolism Disorders; Calcinosis; Kidney Failure, Chronic; Vascular Calcification; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamins; Vitamin K 1; Vitamin K 2
• Other Study ID Numbers: vitamin k in dialysis patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No