Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients

What Was Tested

The trial (phase 4) is built around Vitamin D, K2, Magnesium and Zinc.

Vascular calcification and hence arterial stiffness is of great importance for the high incidence of CVD.

It had four arms (groups): RenaKvit-vessel Active (active comparator), RenaKvit-vessel Control (placebo comparator), RenaKvit-bone Active (active comparator) and RenaKvit-bone control (placebo comparator).

One tablet of non-active drug given once daily.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Whereas atherosclerosis is a dominating cause of CVD in the general population CKD ptt. tend to develop medial calcification and hence arterial stiffness which is thought to be of great importance in the high incidence of CVD.

CKD ptt. in dialysis treatment also have a 3 times higher risk of bone fractures compared to the general population.

The genesis of the arteriosclerosis is still unresolved but seems to be multifactorial.

The impaired kidney function itself and the treatment so far both seem to be of importance.

Who Took Part

Enrollment: 123 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: Age ≥ 18 years old. Life expectancy \> 2 years. Written consent following oral information. Permanent treatment with dialysis ≥ 3 months with either peritoneal or hemodialysis.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: treatment with vitamin k or vitamin k-antagonist by the beginning of the trial or 1 months within; chronic gi-malabsorption leading to a slower bowel transit (e.g. celiac disease, short bowel syndrome); ongoing malignancy (ongoing treatment/clinical controlled visits or diagnosed less than 5 years ago), excl. non-melanoma-skin-cancer (nmsc).

How the Study Was Run

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

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

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

It started in 2016-11 with completion listed for 2020-06-26.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): For RenaKvit-vessel: Changes in arterial stiffness assessed by pulse wave examination reflecting vascular calcification (unit: m/s) (time frame: 2 years). For RenaKvit-bone: Changes in bone mineral density (BMD) in the distal radial bone (unit T-score) (time frame: 2 years).

It also tracked 4 secondary outcomes, for example For RenaKvit-vessel: Changes in coronary vascular and -valve calcification assessed by CT-scans of the heart (unit: Agatston-Score), For RenaKvit-vessel: Changes in vascular calcification measured by changes in blood pressure measurements (unit: mmHg) and For RenaKvit-bone: Changes in body composition, BMD in the lumbar column, hip and whole body (unit: T-score).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vitamin D, K2, Magnesium and Zinc in 123 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.