Actively Recruiting
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways 32) in Adults With Osteopenia or Osteoporosis Carrying a Vitamin D Receptor Gene Variant
Led by S.LAB (SOLOWAYS) · Updated on 2025-03-17
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
S.LAB (SOLOWAYS)
Lead Sponsor
C
Center for New Medical Technologies, Novosibirsk, Russia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and early effects of vitamin K2 (menaquinone-7, MK-7) supplementation in adults aged 40 to 75 years with low bone mineral density, including osteopenia or osteoporosis. The study focuses on individuals carrying a specific "unfavorable" variant in the vitamin D receptor (VDR) gene, comparing them to those without this gene variant. The goal is to see if MK-7 supplementation improves bone health and related markers more in the variant group, who may have a reduced response to vitamin D. Participants will receive vitamin K2 (menaquinone-7) at doses of 100 to 200 micrograms per day along with vitamin D3 at 800 to 1000 IU per day for a period of 6 to 9 months. The study has two groups: one with homozygous carriers of the VDR variant and one control group without the variant. Both groups will follow the same supplementation regimen to compare outcomes related to bone health. During the study, participants will be monitored for changes in bone mineral density over 9 months, along with serum osteocalcin levels, bone turnover markers, vitamin D levels, and quality of life measures. Safety and tolerability will be assessed by recording any treatment-related adverse events. Participants will maintain stable diets and exercise routines, and genotyping will confirm their group assignment. Total participation will last up to 9 months with regular assessments.
CONDITIONS
Brief Title
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score 1.0 or lower)
- Stable dietary habits and willingness to maintain current exercise routine during the study
- Willingness to undergo genetic testing for the vitamin D receptor (VDR) gene variant
- For the VDR Variant Cohort: confirmed homozygous "unfavorable" VDR gene variant (e.g., BsmI or ApaI)
- For the Non-Variant Cohort: confirmed absence of the "unfavorable" VDR gene variant (wild-type)
You will not qualify if you...
- Current or recent (within last 3 months) use of high-dose bisphosphonates, anabolic agents (like teriparatide), or selective estrogen receptor modulators (SERMs)
- Known allergy or sensitivity to vitamin K or vitamin D supplements
- Severe kidney or liver dysfunction, uncontrolled hyperthyroidism, or other significant health conditions affecting bone metabolism
- Pregnancy or breastfeeding
- Unable or unwilling to provide informed consent or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 to 9 months
Participants receive vitamin K2 plus vitamin D3 supplementation to support bone health.
Trial Site Locations
Total: 1 location
1
Center For New Medical Technologies
Novosibirsk, Russia, 630090
Actively Recruiting
Research Team
A
Andrei AV Ponomarenko, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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