Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?

Plain-language guide to NCT02876354: phase 4 interventional trial of Vitamin D, K2, Magnesium and Zinc, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02876354
Phase: phase 4
Status: completed
Start: 2016-08
Completion (planned or actual): 2016-09
Participants: 50 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Vascular Calcifications
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Vitamin D, K2, Magnesium and Zinc.

It is reflected by high plasma levels of dephosphorylated-undercarboxylated Matrix Gla protein (dp-ucMGP) and seems to be correlated with vascular calcifications.

Vascular calcifications can be assessed using the AC24 score on a lateral abdominal X-ray.

It had 1 arm (groups): Menaquinone 360 (experimental).

The registry classes the interventions as drug.

More on the Plan

Background The majority of patients reaching end-stage renal disease (ESRD) and dialysis have vascular calcifications.

In hemodialysis (HD) patients, cardiovascular risk factors are numerous and they include the traditional ones such as age, smoking, diabetes, hypertension, hyperlipidemia and those specific to chronic kidney disease (CKD) as for instance hyperparathyroidism.

All those facts are compelling arguments to look seriously for a treatment against vascular calcifications.

They have included treatments such as statins, non-calcium-based phosphate binders and cinacalcet.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients on chronic hemodialysis in their center older than 18 years old who sign the informed consent.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients who are not eligible for a discontinuation of vitamin k antagonists.

How the Study Was Run

Design: single-group and open-label.

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 2016-08 with completion listed for 2016-09.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Vitamin D, K2, Magnesium and Zinc in 50 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.

Our Notes on the Compound

Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.

Vitamin D, K2, Magnesium and Zinc in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.