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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis; Osteopenia
• Intervention / Treatment: Dietary supplement: Vitamin K2 plus vitamin D3

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrei AV Ponomarenko, MD; Phone Number: +79628316017; Email: dayshadoff@gmail.com

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630090
    • Recruiting
    • Center for New Medical Technologies
    • Contact: Andrei V Ponomarenko, MD; Phone Number: +79628316017; Email: datshadoff@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score ≤ -1.0).
• Stable dietary habits and willingness to maintain current exercise regimen throughout 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 Criteria:

• Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (SERMs). Known allergy or hypersensitivity to vitamin K or vitamin D supplements.
• Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments.
• Pregnancy or breastfeeding.
• Inability or unwillingness to provide informed consent or to comply with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; VDR Variant (Homozygous) Cohort	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.
Experimental: Non-Variant (Control) Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone Mineral Density (BMD)	Assessed by DXA (Dual-Energy X-Ray Absorptiometry) scans	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Osteocalcin Levels		9 months
Change in Bone Turnover Markers	Serum C-Terminal Telopeptide (CTX): Measured in ng/mL as a marker of bone resorption. Serum Procollagen Type I N-Terminal Propeptide (P1NP): Measured in ng/mL as a marker of bone formation. Each marker will be reported separately as the mean change from baseline to 9 months.	9 months
Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0	The number and percentage of participants experiencing treatment-related adverse events will be recorded over the 9-month period. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	9 months
Change in Serum 25(OH) Vitamin D Levels		9 months
Change in Patient-Reported Quality of Life as Measured by the Short Form-36 Health Survey (SF-36)	Patient-reported quality of life will be assessed using the Short Form-36 Health Survey (SF-36), which generates two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each score ranges from 0 to 100, with higher scores indicating a better quality of life. The outcomes will be reported as the mean change in the PCS and MCS scores from baseline to 9 months.	9 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center for New Medical Technologies, Novosibirsk, Russia

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 3, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Vitamin D; Osteoporosis; Osteopenia; Supplements; Vitamin K2
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Osteoporosis; Bone Diseases, Metabolic; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Bone Density Conservation Agents; Micronutrients; Vitamin D; Ergocalciferols; Vitamin K; Vitamins; Cholecalciferol; Vitamin K 2
• Other Study ID Numbers: SW018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No