RecruitingNot ApplicableNCT06867952

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


Sponsor

S.LAB (SOLOWAYS)

Enrollment

40 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Vitamin K2 plus vitamin D3 and Vitamin K2 plus vitamin D3 for people with osteopenia and osteoporosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVitamin 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_SUPPLEMENTVitamin 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

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NCT06867952


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