[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582795":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":23,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":23,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":35,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"S.LAB (SOLOWAYS)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","VDR Variant (Homozygous) Cohort",[13],"Dietary Supplement: Vitamin K2 plus vitamin D3",{"label":15,"type":10,"description":15,"interventionNames":16},"Non-Variant (Control) Cohort",[13],[18,24],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIETARY_SUPPLEMENT","Vitamin K2 plus vitamin D3","Intervention: Vitamin K2 (menaquinone-7), 100-200 µg\u002Fday plus vitamin D3 (800- 1000 IU\u002Fday) for 6-9 months.",[9],null,{"type":19,"name":20,"description":21,"armGroupLabels":25,"otherNames":23},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":23,"email":31},"Andrei AV Ponomarenko, MD","CONTACT","+79628316017","dayshadoff@gmail.com",[33],{"facility":34,"status":35,"city":36,"state":23,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Center For New Medical Technologies","RECRUITING","Novosibirsk","630090","Russia","RU",{"type":41,"coordinates":42},"Point",[43,44],82.93175,55.02259,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":30,"phoneExt":23,"email":49},"Andrei V Ponomarenko, MD","datshadoff@gmail.com",{"type":51,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[53],{"name":54,"class":6},"Center for New Medical Technologies, Novosibirsk, Russia","100582795","a-pilot-study-of-vitamin-k2-menaquinone-7-soloways--in-patients-with-osteopeniaosteoporosis-carrying-a-vdr-gene-variant-100582795",false,"NCT06867952","A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia\u002FOsteoporosis Carrying a VDR Gene Variant","Inclusion Criteria:\n\n* Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score ≤ -1.0).\n* Stable dietary habits and willingness to maintain current exercise regimen throughout the study.\n* Willingness to undergo genotyping for the VDR variant. For the VDR Variant Cohort: confirmed homozygous \"unfavorable\" variant (e.g., BsmI or ApaI).\n* For the Non-Variant Cohort: confirmed absence of the \"unfavorable\" allele (wild-type).\n\nExclusion Criteria:\n\n* 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.\n* Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments.\n* Pregnancy or breastfeeding.\n* Inability or unwillingness to provide informed consent or to comply with study procedures.","ALL","40 Years","75 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","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.",[72,73],"Osteoporosis","Osteopenia",[73,72,75,76,77],"Supplements","Vitamin K2","Vitamin D","2025-03-14",{"date":80,"type":81},"2025-03-17","ACTUAL",{"date":83,"type":81},"2024-05-03",{"date":85,"type":66},"2026-03-03",{"name":5,"class":6},1]