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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-25

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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End Stage Renal Disease on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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vitamin k1

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

Group Type ACTIVE_COMPARATOR

Vitamin K1

Intervention Type DRUG

vitamin k1 tablets

vitamin k2

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

Group Type ACTIVE_COMPARATOR

Vitamin k2

Intervention Type DRUG

vitamin k2 45 ug tablets twice daily

placebo

placebo will be given daily per oral for 3 months

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo tablets

Interventions

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Vitamin K1

vitamin k1 tablets

Intervention Type DRUG

Vitamin k2

vitamin k2 45 ug tablets twice daily

Intervention Type DRUG

placebo

placebo tablets

Intervention Type OTHER

Other Intervention Names

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Phylloquinone menaquinone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No