Clinical Trial

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

Recruiting
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Record status
This record was last updated March 17, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-04.
Trial Details
NCT Number NCT06867952
Lead Sponsor S.LAB (SOLOWAYS)
Collaborators: Center for New Medical Technologies, Novosibirsk, Russia
Conditions Osteoporosis, Osteopenia
Enrollment 40 participants
Start Date 2024-05-03
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2025-03-17