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

NCT06867952 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-17

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Center for New Medical Technologies, Novosibirsk, Russia

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2026-02-28
Completion
2026-03-03

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867952 on ClinicalTrials.gov