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

Last updated: March 14, 2025
Sponsor: S.LAB (SOLOWAYS)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Osteopenia

Treatment

Vitamin K2 plus vitamin D3

Clinical Study ID

NCT06867952
SW018
  • Ages 40-75
  • All Genders

Study 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

Inclusion Criteria:

  • Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia orosteoporosis (T-score ≤ -1.0).

  • Stable dietary habits and willingness to maintain current exercise regimenthroughout 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

Exclusion Criteria:

  • Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (SERMs). Knownallergy or hypersensitivity to vitamin K or vitamin D supplements.

  • Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or othersignificant comorbidities that could confound bone metabolism assessments.

  • Pregnancy or breastfeeding.

  • Inability or unwillingness to provide informed consent or to comply with studyprocedures.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Vitamin K2 plus vitamin D3
Phase:
Study Start date:
May 03, 2024
Estimated Completion Date:
March 03, 2026

Study 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.

Connect with a study center

  • Center For New Medical Technologies

    Novosibirsk, 630090
    Russian Federation

    Active - Recruiting

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