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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
Center For New Medical Technologies
Novosibirsk, Russia
RECRUITINGChange in Bone Mineral Density (BMD)
Assessed by DXA (Dual-Energy X-Ray Absorptiometry) scans
Time frame: 9 months
Change in Serum Osteocalcin Levels
Time frame: 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.
Time frame: 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).
Time frame: 9 months
Change in Serum 25(OH) Vitamin D Levels
Time frame: 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.
Time frame: 9 months
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