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RECRUITING
NCT06867952
NA

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

Sponsor: S.LAB (SOLOWAYS)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-05-03

Completion Date

2026-03-03

Last Updated

2025-03-17

Healthy Volunteers

No

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.

Locations (1)

Center For New Medical Technologies

Novosibirsk, Russia