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

RecruitingNAAges 40 Years - 75 YearsAllS.LAB (SOLOWAYS)
NCT06867952 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vitamin K2 plus vitamin D3
  • Vitamin K2 plus vitamin D3
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Where

1 site
Center For New Medical Technologies
Novosibirsk, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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