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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    S.LAB (SOLOWAYS)
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Updated on 11 March 2025
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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.

Description

Vitamin D receptor (VDR) polymorphisms have been associated with varying responses to vitamin D and calcium supplementation, ultimately influencing bone health. Menaquinone-7 (vitamin K2) is crucial for carboxylation of osteocalcin, facilitating calcium deposition in bone. This study investigates whether individuals with an "unfavorable" VDR gene variant - who might have lower basal responsiveness to vitamin D - experience enhanced benefit from MK-7 supplementation in conjunction with a standard vitamin D3 regimen. By focusing on this genotype-stratified approach, the study aims to generate preliminary data supporting the role of personalized supplementation strategies in skeletal health.

Details
Condition Osteoporosis, Osteopenia
Age 40years - 75years
Clinical Study IdentifierNCT06867952
SponsorS.LAB (SOLOWAYS)
Last Modified on11 March 2025

Eligibility

 Yes No Not Sure

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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