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Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)

Plain-language guide to NCT02517580: phase 2 interventional trial of Vitamin D, K2, Magnesium and Zinc, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02517580
Phase
phase 2
Status
completed
Start
2015-03
Completion (planned or actual)
2016-05
Participants
60 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Arterial Stiffness; Vitamin K2 Deficiency
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Vitamin D, K2, Magnesium and Zinc.

It had 1 arm (groups): Vitamin K2 (MK7) (experimental).

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 60 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: Functional renal graft. Stable renal function for at least 3 months prior to enrollment.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: history of thrombotic events; diagnosed coagulopathy; cardiovascular event in the past month prior to enrollment.

How the Study Was Run

The set-up was 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 2015-03 with completion listed for 2016-05.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks, Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks and Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Vitamin D, K2, Magnesium and Zinc in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.

Related Pages

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.