Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

It had four arms (groups): Vitamin K2 group (active comparator), Cholecalciferol group (active comparator), Vitamin K2 and Cholecalciferol group (active comparator) and Control group (no intervention).

The registry classes the interventions as drug.

More on the Plan

Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries \[3, 4\].

It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus.

However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Patients aged 6-18 years. Patients on hemodialysis since 3 months or longer. Hemodialysis frequency 3 times or more weekly.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: patients with life expectancy \< 3 months; patients taking warfarin; patients with known intestinal malabsorption.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Vitamin D, K2, Magnesium and Zinc was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-09-01 with completion listed for 2020-01-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Uncarboxylated MGP (time frame: 4 months). Uncarboxylated osteocalcin (time frame: 4 months).

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 60 people.

Its status is unknown; 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.