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
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Dialysis
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
Sites / Locations
- Ainshams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
No
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
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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
background
Learn more about this trial
Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
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