A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant

What Was Tested

This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.

It had two arms (groups): Intervention (experimental) and Non-Variant (Control) Cohort (experimental).

VDR Variant (Homozygous) Cohort.

Non-Variant (Control) Cohort.

The registry classes the interventions as dietary supplement.

More on the Plan

Menaquinone-7 (vitamin K2) is crucial for carboxylation of osteocalcin, facilitating calcium deposition in bone.

By focusing on this genotype-stratified approach, the study aims to generate preliminary data supporting the role of personalized supplementation strategies in skeletal health.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score ≤ -1.0). Stable dietary habits and willingness to maintain current exercise regimen throughout the study. Willingness to undergo genotyping for the VDR variant. For the VDR Variant Cohort: confirmed homozygous "unfavorable" variant (e.g., BsmI or ApaI). For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: pregnancy or breastfeeding; inability or unwillingness to provide informed consent or to comply with study procedures.

How the Study Was Run

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

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

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

It started in 2024-05-03 with completion listed for 2026-02-28.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Bone Mineral Density (BMD) (time frame: 9 months).

It also tracked 5 secondary outcomes, for example Change in Serum Osteocalcin Levels, Change in Bone Turnover Markers, Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change in Serum 25(OH) Vitamin D Levels and Change in Patient-Reported Quality of Life as Measured by the Short Form-36 Health Survey (SF-36).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Vitamin D, K2, Magnesium and Zinc in 40 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.