Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

What Was Tested

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

The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population.

This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms.

It had two arms (groups): Vitamin K2 (experimental) and Standard Therapy (no intervention).

Subjects randomised to standard therapy will continue to receive dialysis and chronic kidney disease-metabolic bone disease (CKD-MBD) management in accordance to current best practise guidelines.

The registry classes the interventions as drug.

Who Took Part

The registry lists 178 actual participants took part.

It was open to people of any sex aged from 21 years up to 80 years.

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

Examples of who could join: Age ≥ 45 years and less than 80 years. At least 12 months on Hemodialysis. Coronary artery calcium score of ≥ 30 in the baseline Multislice Computed Tomography. Able to give informed consent. Life expectancy of at least18 months.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: history of thrombosis in the last 6 months except vascular access thrombosis; need for vitamin k antagonists therapy at baseline or in the 3 months prior to baseline; liver dysfunction.

How the Study Was Run

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

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Vitamin D, K2, Magnesium and Zinc study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-07 with completion listed for 2022-02.

It ran at 1 site in Singapore.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Absolute difference in coronary artery calcium score at 18-month between control and intervention arms (time frame: 18 months).

It also tracked 7 secondary outcomes, for example Absolute difference in AVC score at 18-months, Absolute difference in cfPWV and AI at 18-months, Mortality from any cause within the study period and Difference in plasma levels of dp-ucMGP at 18 months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vitamin D, K2, Magnesium and Zinc in 178 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.