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

What Was Tested

The trial (phase 2, phase 3) is built around Vitamin D, K2, Magnesium and Zinc.

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.

It had three arms (groups): vitamin k1 (active comparator), vitamin k2 (active comparator) and placebo (placebo comparator).

Placebo will be given daily per oral for 3 months.

The registry classes the interventions as drug and other.

More on the Plan

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 .

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2020-07-25 with completion listed for 2020-11-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): change in serum level of Uncarboxylated MGP (time frame: change between baseline and after 3 months).

It also tracked 3 secondary outcomes, for example parathyroid hormone, serum calcium level and serum phosphate level.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vitamin D, K2, Magnesium and Zinc in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.