Clinical Trials

Numerous clinical trials evaluate the therapeutic efficacy, safety, and pharmacokinetics of Vitamin K2 (Menaquinone) across diverse indications, primarily bone disorders like osteoporosis and osteopenia, cardiovascular and metabolic diseases, nephrolithiasis, nocturnal leg cramps, and prostate cancer. Spanning Early Phase 1 through Phase 4 alongside non-phase assessments, these studies encompass completed, active, recruiting, and not yet recruiting stages. Interventions are sponsored predominantly by academic medical centers, university health networks, and research institutes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07620236 NOT_YET_RECRUITING
Infant Vitamin K Status; Vitamin K Deficiency Bleeding
Norfolk and Norwich University Hospitals NHS Foundation Trust
 2026-10-01
NCT05259046 ACTIVE_NOT_RECRUITING
Coronary Artery Calcification; Arterial Stiffness
Bispebjerg Hospital
 2022-06-21
NCT06817512 ACTIVE_NOT_RECRUITING
Ischemic Stroke
Harbin Medical University
 2025-03-23
NCT06385275 ACTIVE_NOT_RECRUITING
Osteo Arthritis Knee
Boston University
 2025-06-03 PHASE1; PHASE2
NCT05943457 RECRUITING
Migraine Headache; Arterial Stiffness; Vitamin K Deficiency
Sola Aoun Bahous, M.D. Ph.D.
 2024-03-06
NCT05942053 RECRUITING
Chronic Kidney Diseases
Tanta University
 2023-07-15 PHASE4
NCT05500443 COMPLETED
Coronary Artery Disease
Odense University Hospital
 2023-02-08
NCT07206537 RECRUITING
Pediatrics Nephrology
Ain Shams University
 2025-04-01
NCT06867952 RECRUITING
Osteoporosis; Osteopenia
S.LAB (SOLOWAYS)
 2024-05-03
NCT06707909 RECRUITING
Socket Preservation
Cairo University
 2025-02-15 PHASE4
NCT07574242 COMPLETED
Atopic Dermatitis
October 6 University
 2024-08-03
NCT07403942 COMPLETED
Skin Aging of Face and Neck
Nanjing Ascend Biotech Technology Co., Ltd.
 2024-12-26
NCT04010578 UNKNOWN
Coronary Artery Disease; Carotid Artery Disease
Academisch Ziekenhuis Maastricht
 2024-01-01
NCT05375630 UNKNOWN
Diabete Type 2
Dasman Diabetes Institute
 2022-03-21
NCT05356936 COMPLETED
Post-acute COVID-19 Syndrome
University Hospitals Cleveland Medical Center
 2022-06-01
NCT06358443 Not yet recruiting
Osteoporosis|Osteopenia
Meddoc|Tine
 2024-04-02 Not Applicable
NCT05547750 COMPLETED
Nocturnal Leg Cramps
The Third People's Hospital of Chengdu
 2022-10-01
NCT05995522 COMPLETED
Overweight and Obesity; Cardiometabolic Risk Factors
University of Guadalajara
 2023-09-01
NCT05161975 UNKNOWN
Muscle Atrophy; Cachexia
Lithuanian Sports University
 2021-12-15
NCT05689632 UNKNOWN
Obesity; Vitamin D3 Deficiency
Hospital Universitario Pedro Ernesto
 2022-07-15
NCT04676958 COMPLETED
Inflammation; Oxidative Stress; Vitamin K; Exercise; Strength; Recovery
University of Glasgow
 2021-04-01
NCT05802121 Not yet recruiting
Prostate Cancer|Metabolic Syndrome|Obesity|Cardiovascular Morbidity|Bone Diseases|Hyperlipidemias|Diabetes
Western University
 2023-06 Early Phase 1
NCT05675163 COMPLETED
Oxidative Stress; Inflammation
NIZO Food Research
 2022-11-15
NCT05592509 COMPLETED
Oxidative Stress; Inflammation
S&R Farmaceutici S.p.A.
 2022-09-15
NCT03871322 UNKNOWN
Fracture Healing; Vitamin D3; Deficiency of Vitamin K2
Medical University of Bialystok
 2019-07-01
NCT04429035 UNKNOWN
Aortic Valve Stenosis; Aortic Valve Calcification; Mitral Annular Calcification; Mitral Valve Calcification; Mitral Valve Stenosis
National and Kapodistrian University of Athens
 2019-09-23
NCT05081960 Active not recruiting
Kidney Calculi|Calcium Oxalate Kidney Stones|Vitamin K 2|Human|Kidney Stone|Calcium Oxalate Urolithiasis|Calcium Phosphate Urolithiasis|Nephrolithiasis
Lawson Health Research Institute|St. Joseph''s Health Care London
 2022-08-01 --
NCT05436483 Unknown status
Health Subjective
Peking University Third Hospital
 2022-07-31 --
NCT04780061 TERMINATED
Covid19
The Canadian College of Naturopathic Medicine
 2021-07-12 PHASE3
NCT04770740 COMPLETED
Covid19
Canisius-Wilhelmina Hospital
 2021-02-22
NCT02870829 COMPLETED
Vascular Calcification; Systemic and Arterial Stiffness; Complication of Hemodialysis; Deficiency of Vitamin K2
National University Health System, Singapore
 2016-07 PHASE2
NCT03311321 UNKNOWN
Cardiovascular Diseases; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5; Vitamin K Deficiency; Hemodialysis
Augusta University
 2017-09-13
NCT03243890 COMPLETED
Aortic Valve Stenosis; Multidetector Computed Tomography; Vitamin K 2; Randomised Clinical Trial
Axel Diederichsen
 2018-01-12
NCT02959762 UNKNOWN
Obesity; Insulin Resistance; Obesity in Diabetes; Nutritional and Metabolic Diseases; Hyperlipidemia; Hyperglycemia; Cardiovascular Diseases
Augusta University
 2016-10
NCT03305536 UNKNOWN
Aortic Valve Disease
Hopital St. Georges, Ajaltoun
 2018-01-02 PHASE2
NCT04477811 COMPLETED
End Stage Renal Disease on Dialysis
Ain Shams University
 2020-07-25 PHASE2; PHASE3
NCT04189796 COMPLETED
Healthy Women; Osteocalcin
Prof Stig Larsen
 2020-01-16
NCT01972113 UNKNOWN
Obesity; Insulin Resistance; Insulin Sensitivity; Prediabetes; Dyslipidemia; Diabetes
Augusta University
 2013-09
NCT02976246 COMPLETED
Vitamin K Supplementation; Endstage Renal Disease; Cardiovascular Disease; Bone Disease
Zealand University Hospital
 2016-11 PHASE4
NCT02366481 UNKNOWN
Obesity; Insulin Resistance; Insulin Sensitivity; Beta-Cell Dysfunction; Prediabetes
Augusta University
 2015-02
NCT04145492 UNKNOWN
End Stage Renal Disease
Ain Shams University
 2019-09-01 PHASE2; PHASE3
NCT02917525 UNKNOWN
Aortic Valve Stenosis; Bicuspid Aortic Valve
Maastricht University Medical Center
 2016-08 PHASE2
NCT03897660 COMPLETED
Healthy
Université de Sherbrooke
 2019-03-29
NCT01002157 UNKNOWN
Coronary Artery Disease
Maastricht University Medical Center
 2011-10
NCT02970084 COMPLETED
Carotid Plaques
Scientific Institute San Raffaele
 2016-11
NCT02610933 COMPLETED
Vascular Calcification
Onze Lieve Vrouw Hospital
 2015-11 PHASE4
NCT02839044 COMPLETED
Arterial Calcification; Diabetes Mellitus Type 2
UMC Utrecht
 2016-06
NCT02404519 UNKNOWN
Vascular Stiffness
Maastricht University Medical Center
 2016-01
NCT04539418 COMPLETED
Renal Disease
Catholic University of Salta
 2016-12-01 PHASE4
NCT02876354 COMPLETED
Vascular Calcifications
Saint-Joseph University
 2016-08 PHASE4
NCT02517580 COMPLETED
Arterial Stiffness; Vitamin K2 Deficiency
Lebanese American University
 2015-03 PHASE2
NCT01923012 UNKNOWN
Carotid Disease; Atherosclerosis
Azienda Ospedaliera Sant'Anna
 2013-09 PHASE2
NCT01533441 COMPLETED
Thrombosis
Danisco
 2012-02 PHASE2
NCT00548509 COMPLETED
Osteoporosis
Eisai Limited
 2002-02-01 PHASE4
NCT01143831 COMPLETED
Thrombosis
Stephan Moll, MD
 2009-11
NCT01928134 COMPLETED
Healthy
Changhua Christian Hospital
 2011-04
NCT00642551 COMPLETED
Bone Loss; Arteriosclerosis
Maastricht University Medical Center
 2008-03
NCT01675206 COMPLETED
Vascular Calcification
Rogier Caluwe
 2011-05 PHASE3
NCT01638182 COMPLETED
Bone Health; Vascular Health
Maastricht University Medical Center
 2011-03
NCT04382027 COMPLETED
Healthy
Université de Sherbrooke
 2010-11-11
NCT01638143 COMPLETED
Bioequivalence; Bioavailability
Maastricht University Medical Center
 2010-11
NCT01101698 UNKNOWN
Kidney Diseases; Coronary Artery Calcification
Medical University of Lodz
 2009-06 PHASE4
NCT01194778 COMPLETED
Carboxylation Level; Vitamin K-dependent Proteins
Maastricht University Medical Center
 2009-10
NCT00858767 COMPLETED
Bioavailability
Maastricht University Medical Center
 2008-10
NCT00742768 COMPLETED
Healthy
Maastricht University Medical Center
 2008-06
NCT01407601 COMPLETED
CKD 5D, Hemodialysis
RWTH Aachen University
 2008-01 PHASE3
NCT00732576 COMPLETED
Atherosclerosis
Maastricht University Medical Center
 2008-01
NCT00512928 COMPLETED
Healthy
Maastricht University
 2007-09
NCT00483431 COMPLETED
Vitamin K-status
Maastricht University Medical Center
 2007-05
NCT00402974 COMPLETED
Healthy
UMC Utrecht
 2007-01

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Vitamin K2 (Menaquinone) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vitamin K2 serves as an essential cofactor for gamma-glutamyl carboxylase, facilitating the post-translational carboxylation and activation of vitamin K-dependent proteins such as osteocalcin and matrix Gla protein. This carboxylation process promotes proper calcium deposition into the extracellular bone matrix while preventing soft tissue calcification, thereby enhancing bone mineral density and suppressing arterial mineralization. Consequently, this targeted biochemical cascade underpins the clinical application of Vitamin K2 in managing metabolic bone disorders such as osteoporosis and reducing cardiovascular morbidity.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.