NCT06867952 A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
| NCT ID | NCT06867952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | S.LAB (SOLOWAYS) |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-05-03 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06867952 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867952 currently recruiting?
Yes, NCT06867952 is actively recruiting participants. Contact the research team at dayshadoff@gmail.com for enrollment information.
Where is the NCT06867952 trial being conducted?
This trial is being conducted at Novosibirsk, Russia.
Who is sponsoring the NCT06867952 clinical trial?
NCT06867952 is sponsored by S.LAB (SOLOWAYS). The trial plans to enroll 40 participants.