A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorS.LAB (SOLOWAYS)
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vitamin K2 plus vitamin D3
- Vitamin K2 plus vitamin D3
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
S.LAB (SOLOWAYS)
Lead sponsor
Center for New Medical Technologies, Novosibirsk, Russia
Collaborator
Source ClinicalTrials.gov