Role of Vitamin K2 in Chronic Kidney Disease

What Was Tested

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

This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Vitamin K2 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease.

It had two arms (groups): Group 1: Control group (placebo comparator) and Vitamin K2 (menaquinone-7) (active comparator).

The registry classes the interventions as drug.

More on the Plan

It varies depending on the amount of blood pressure control, the degree of proteinuria, the previous rate of decline in GFR, and the underlying renal disease, including diabetes.

FGF-23 is a hormone with a molecular weight of 30 kDa works on fibroblast growth factor receptors (FGFR1-4) in the kidney, heart, colon, and parathyroid gland.

It is secreted by osteocytes and, to a lesser extent by osteoblasts into the bloodstream.

A rise in FGF-23 could indicate kidney dysfunction, and concurrent bone disease.

Who Took Part

Enrollment: 44 planned participants were the target.

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. Patients matched in the duration of CKD. Patients with serum Potassium \< 5 mEq/L. A newly diagnosed patients with hypertension.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: patients with elevated level of potassium ≥ 5 meq/l; patients with diabetes; patients with cancer.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

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 and investigator.

It started in 2023-07-15 with completion listed for 2026-07-14.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021 (time frame: The study duration will be 6 months). The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g) (time frame: The study duration will be 6 months). The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer (time frame: The study duration will be 6 months).

It also tracked 6 secondary outcomes, for example The change in I-PTH (pg/ml), The change in vitamin D level (ng/ml), The change in serum calcium level (mg/dl), The change in serum phosphorus level (mg/dl) and Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vitamin D, K2, Magnesium and Zinc in 44 people.

It is still recruiting; 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.