Vitamin K2 supplementation for patients with low bone density and a specific gene variant
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
This study is testing if taking vitamin K2 can help improve bone density in adults aged 40-75 with low bone density who have a specific gene variant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | S.lab (Soloways) Academic / other |
| Locations | 1 site (Novosibirsk) |
| Trial ID | NCT06867952 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the safety and preliminary efficacy of vitamin K2 (menaquinone-7) supplementation in adults aged 40-75 with osteopenia or osteoporosis who carry a specific variant in the vitamin D receptor (VDR) gene. The study compares two groups: those with the VDR variant and those without, to assess improvements in bone mineral density and related biomarkers. Participants will receive vitamin K2 alongside a standard vitamin D3 regimen, with the hypothesis that those with the VDR variant will show greater benefits from the supplementation. The trial aims to provide insights into personalized supplementation strategies for better bone health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 with a confirmed diagnosis of osteopenia or osteoporosis and a specific VDR gene variant.
Not a fit: Patients who do not have the VDR gene variant or those with severe comorbidities affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized treatment strategies for improving bone health in patients with specific genetic profiles.
How similar studies have performed: While there is ongoing research into vitamin K2 and bone health, this genotype-stratified approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Novosibirsk
- Center For New Medical Technologies — Novosibirsk, Russia (Recruiting)
Study contacts
- Study coordinator: Andrei AV Ponomarenko, MD
- Email: dayshadoff@gmail.com
- Phone: +79628316017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.