Vitamin K2 Study for Weak Bones With a VDR Gene Variant
Tests vitamin K2 with vitamin D3 in people with weak bones and a VDR variant.
Key facts
- Who runs it
- S.LAB (SOLOWAYS)
- Where
- Novosibirsk, RussiaSee the site
- Trial code
- Registry title
- A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 3 May 2024
- Planned end
- 3 Mar 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Vitamin K2 plus vitamin D3
- Record updated
- 17 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40-75 with low bone density (osteopenia or osteoporosis) who agree to a gene test for a vitamin D receptor (VDR) variant.
- Age
- 40 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Osteopenia or osteoporosis confirmed by a DXA scan (T-score ≤ -1.0).
- Earlier treatment
- Cannot have used high-dose bisphosphonates, anabolic agents (for example teriparatide) or SERMs in the last 3 months.
- Biomarker or test result
- One group has two copies of the unfavorable VDR variant (for example BsmI or ApaI). The other group has no unfavorable variant (wild-type).
Main reasons for not taking part
- Use of high-dose bisphosphonates, anabolic agents or SERMs in the last 3 months
- Known allergy to vitamin K or vitamin D supplements
- Severe kidney or liver problems, uncontrolled hyperthyroidism, or other major illness that could affect bone tests
- Pregnancy or breastfeeding
- Unable or unwilling to consent or follow study procedures
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Pregnancy or breastfeeding
- Inability or unwillingness to provide informed consent or to comply with study procedures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in Russia
- Center for New Medical TechnologiesNovosibirsk, RussiaContact: Andrei V Ponomarenko, MDTaking people
About the trial
What the trial wants to find out
This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of vitamin K2 (menaquinone-7, MK-7) supplementation in patients with low bone mineral density (osteopenia or osteoporosis) who carry a specific "unfavorable" variant in the vitamin D receptor (VDR) gene (e.g., BsmI or ApaI polymorphisms). The trial will compare improvements in bone health and related biomarkers between two cohorts: (1) homozygous carriers of the VDR variant and (2) non-variant carriers (wild-type). Investigators hypothesize that MK-7 supplementation will lead to greater improvements in bone mineral density (BMD) and bone turnover markers in the homozygous variant group due to their potentially reduced baseline response to vitamin D signaling.
The 2 groups in the trial
- InterventionTreatment being tested
VDR Variant (Homozygous) Cohort
Treatment: Vitamin K2 plus vitamin D3
- Non-Variant (Control) CohortTreatment being tested
Treatment: Vitamin K2 plus vitamin D3
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
- Plain-language title
- Vitamin K2 Study for Weak Bones With a VDR Gene VariantGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06867952, who can take part
- Record updated
- 17 March 2025