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

NCT06867952 | Recruiting DMC

• 1 other identifier: SW018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Osteopenia

Keywords

Osteopenia; Osteoporosis; Supplements; Vitamin K2; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in Bone Mineral Density (BMD)

  Assessed by DXA (Dual-Energy X-Ray Absorptiometry) scans

  9 months

Secondary Outcomes (5)

• Change in Serum Osteocalcin Levels

  9 months

• Change in Bone Turnover Markers

  9 months

• Adverse Events and TolerabilityIncidence of Treatment-Related Adverse Events as Assessed by 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)

  9 months

Study Arms (2)

Intervention

EXPERIMENTAL

VDR Variant (Homozygous) Cohort

Dietary Supplement: Vitamin K2 plus vitamin D3

Non-Variant (Control) Cohort

EXPERIMENTAL

Non-Variant (Control) Cohort

Dietary Supplement: Vitamin K2 plus vitamin D3

Interventions

Vitamin K2 plus vitamin D3 DIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Center For New Medical Technologies

Novosibirsk, 630090, Russia

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Vitamin K 2; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Andrei AV Ponomarenko, MD

CONTACT

+79628316017; dayshadoff@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 10, 2025
• Study Start: May 3, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 3, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)