NCT06867952

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: S.LAB (SOLOWAYS) · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin K2 plus vitamin D3	Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
DIETARY_SUPPLEMENT	Vitamin K2 plus vitamin D3	Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-02-28
• Completion: 2026-03-03
• First posted: 2025-03-10
• Last updated: 2025-03-17

Locations

1 site across 1 country: Russia