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

Primary Purpose

End Stage Renal Disease on Dialysis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Vitamin K1

Vitamin k2

placebo

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ainshams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin k1

vitamin k2

placebo

Arm Description

vitamin k1 will be given 10 mg thrice a week for 3 months

vitamin k2 (menaquinone) will be given 90 ug per day orally

placebo will be given daily per oral for 3 months

Outcomes

Primary Outcome Measures

change in serum level of Uncarboxylated MGP

Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification

Secondary Outcome Measures

parathyroid hormone

measuring change in serum PTH

serum calcium level

measuring the change in serum calcium level

serum phosphate level

measuring the change in phosphate level

Full Information

NCT ID

NCT04477811

First Posted

July 13, 2020

Last Updated

July 19, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04477811

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 25, 2020 (Actual)

Primary Completion Date

November 1, 2020 (Actual)

Study Completion Date

January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease on Dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin k1

Arm Type

Active Comparator

Arm Description

vitamin k1 will be given 10 mg thrice a week for 3 months

Arm Title

vitamin k2

Arm Type

Active Comparator

Arm Description

vitamin k2 (menaquinone) will be given 90 ug per day orally

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo will be given daily per oral for 3 months

Intervention Type

Drug

Intervention Name(s)

Vitamin K1

Other Intervention Name(s)

Phylloquinone

Intervention Description

vitamin k1 tablets

Intervention Type

Drug

Intervention Name(s)

Vitamin k2

Other Intervention Name(s)

menaquinone

Intervention Description

vitamin k2 45 ug tablets twice daily

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo tablets

Primary Outcome Measure Information:

Title

change in serum level of Uncarboxylated MGP

Description

Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification

Time Frame

change between baseline and after 3 months

Secondary Outcome Measure Information:

Title

parathyroid hormone

Description

measuring change in serum PTH

Time Frame

change between baseline and after 3 months

Title

serum calcium level

Description

measuring the change in serum calcium level

Time Frame

change between baseline and after 3 months

Title

serum phosphate level

Description

measuring the change in phosphate level

Time Frame

change between baseline and after 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

sarah fahmy

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ainshams University

City

Cairo

ZIP/Postal Code

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24533939

Citation

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.

Results Reference

background

PubMed Identifier

24212088

Citation

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.

Results Reference

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

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