An interventional study of Vitamin K2 plus vitamin D3 and Vitamin K2 plus vitamin D3 in Osteoporosis and Osteopenia, sponsored by S.LAB (SOLOWAYS). Recruiting at 1 site in Russian Federation. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Treatment
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.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 40 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →S.LAB (SOLOWAYS) is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VDR Variant (Homozygous) Cohort
Dietary Supplement: Vitamin K2 plus vitamin D3
Non-Variant (Control) Cohort
Dietary Supplement: Vitamin K2 plus vitamin D3
Drug pages: Vitamin K 2 · Cholecalciferol
Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
Drug pages: Vitamin K 2 · Cholecalciferol
Intervention: Vitamin K2 (menaquinone-7), 100-200 µg/day plus vitamin D3 (800- 1000 IU/day) for 6-9 months.
Change 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
Plan to share: No
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Studies of the drugs tested here: Vitamin K 2 · Cholecalciferol
S.LAB (SOLOWAYS)