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Completed

NCT Number: NCT04477811

Comparative Study Evaluating the Effect 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.

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Key information

Conditions

End Stage Renal Disease on Dialysis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ainshams University

Cairo, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin K1

Drug

vitamin k1 tablets

Other names: Phylloquinone

Vitamin K2

Drug

vitamin k2 45 ug tablets twice daily

Other names: menaquinone

Placebo

Other

placebo tablets

Primary outcomes

  1. change in serum level of Uncarboxylated MGP

    Time frame: change between baseline and after 3 months

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

Secondary outcomes

  1. parathyroid hormone

    Time frame: change between baseline and after 3 months

    measuring change in serum PTH

  2. serum calcium level

    Time frame: change between baseline and after 3 months

    measuring the change in serum calcium level

  3. serum phosphate level

    Time frame: change between baseline and after 3 months

    measuring the change in phosphate level

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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