Recruiting

Vitamin K2 for Osteopenia/Osteoporosis with VDR Gene Variant

What is being tested

Vitamin K2 plus vitamin D3

Dietary Supplement

Who is being recruted

Bone Diseases+3

+ Bone Diseases, Metabolic

+ Metabolic Diseases

From 40 to 75 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: May 2024

See protocol details

Summary

Principal SponsorS.LAB (SOLOWAYS)

Study ContactAndrei AV Ponomarenko, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 3, 2024

Actual date on which the first participant was enrolled.

This study explores the potential benefits of a supplement called Menaquinone-7, or Vitamin K2, for people who have a specific variant in their Vitamin D receptor (VDR) gene. These individuals may not respond as well to standard Vitamin D and calcium treatments for bone health, leading to conditions like osteopenia or osteoporosis. The research aims to see if adding Vitamin K2 to a regular Vitamin D3 regimen could improve bone health in those with the "unfavorable" VDR gene variant. This approach could help tailor treatments for better management of bone health issues. Participants in the study will receive Vitamin K2 along with their usual Vitamin D3 supplements. The study will monitor how well the bones use calcium, which is crucial in strengthening them. Researchers will evaluate the effectiveness of this treatment strategy by observing any changes in bone health. This could lead to more personalized approaches in treating bone conditions, potentially providing greater benefits for those with specific genetic backgrounds.

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

NCT06867952

Principal SponsorS.LAB (SOLOWAYS)

Study ContactAndrei AV Ponomarenko, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosis

Criteria

4 inclusion criteria required to participate

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).

4 exclusion criteria prevent from participating

Pregnancy or breastfeeding.

Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (SERMs). Known allergy or hypersensitivity to vitamin K or vitamin D supplements.

Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments.

Inability or unwillingness to provide informed consent or to comply with study procedures.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

VDR Variant (Homozygous) Cohort

Group II

Experimental

Non-Variant (Control) Cohort

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Center For New Medical Technologies

Novosibirsk, RussiaOpen Center For New Medical Technologies in Google Maps

Recruiting

One Study Center