NCT04477811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 13, 2020

Last Update Submit

July 19, 2021

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • parathyroid hormone

    change between baseline and after 3 months

  • serum calcium level

    change between baseline and after 3 months

  • serum phosphate level

    change between baseline and after 3 months

Study Arms (3)

vitamin k1

ACTIVE COMPARATOR

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

Drug: Vitamin K1

vitamin k2

ACTIVE COMPARATOR

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

Drug: Vitamin k2

placebo

PLACEBO COMPARATOR

placebo will be given daily per oral for 3 months

Other: placebo

Interventions

Vitamin K1DRUG

vitamin k1 tablets

Also known as: Phylloquinone
vitamin k1
Vitamin k2DRUG

vitamin k2 45 ug tablets twice daily

Also known as: menaquinone
vitamin k2
placeboOTHER

placebo tablets

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams University

Cairo, 02, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 24533939BACKGROUND

  • 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.

    PMID: 24212088BACKGROUND

MeSH Terms

Interventions

Vitamin K 1Vitamin K 2

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • sarah fahmy

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 20, 2020

Study Start

July 25, 2020

Primary Completion

November 1, 2020

Study Completion

January 1, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)