Clinical Trials

Numerous clinical trials evaluate Vitamin K1 across diverse indications, including coagulation disorders, vascular calcification, osteoarthritis of the knee, epidermal growth factor receptor inhibitor-induced skin toxicity, and glioblastoma. Spanning Early Phase 1 through Phase 4 interventional and observational designs, these studies encompass active recruiting, completed, active not recruiting, and terminated recruitment statuses. Sponsored by academic universities, medical research centers, and biopharmaceutical entities, these investigations aim to establish therapeutic utility in managing bleeding, bone health, and oncological comorbidities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05018221 RECRUITING
Calciphylaxis
University of Sydney
 2021-08-26 PHASE3
NCT06385275 ACTIVE_NOT_RECRUITING
Osteo Arthritis Knee
Boston University
 2025-06-03 PHASE1; PHASE2
NCT04752813 ACTIVE_NOT_RECRUITING
Glioblastoma; Glioblastoma Multiforme
BPGbio
 2022-08-22 PHASE2
NCT06839352 COMPLETED
Variceal Bleeding
Zagazig University
 2022-10-03 PHASE4
NCT05505552 Recruiting
Osteo Arthritis Knee
Tufts University|University of North Carolina Chapel Hill|Tufts Medical Center
 2023-09-20 Not Applicable
NCT05610137 Completed
Dietary Intake
Vanessa Corrales Agudelo|Vidarium Nutrition Health and Wellness Research Center
 2022-10-18 --
NCT05392127 COMPLETED
Rheumatoid Arthritis
Jiangsu HengRui Medicine Co., Ltd.
 2022-07-15 PHASE1
NCT05273775 COMPLETED
Chronic Hepatitis B
Jiangsu HengRui Medicine Co., Ltd.
 2022-04-29 PHASE1
NCT04477811 COMPLETED
End Stage Renal Disease on Dialysis
Ain Shams University
 2020-07-25 PHASE2; PHASE3
NCT01742273 TERMINATED
Cardiovascular Diseases
RWTH Aachen University
 2013-10 PHASE3
NCT01528800 COMPLETED
End-stage Kidney Disease
Dr. Rachel Holden
 2012-11 PHASE2
NCT05060809 COMPLETED
Vascular Calcification
Assiut University
 2018-01-01 PHASE4
NCT03388970 UNKNOWN
Intracerebral Haemorrhage in Cerebellum
HUANG XIANJIAN
 2017-08-01 EARLY_PHASE1
NCT05060809 Completed
Vascular Calcification
Assiut University
 2018-01-01 Phase 4
NCT02324686 COMPLETED
End Stage Renal Failure on Dialysis; Atrial Fibrillation
University Health Network, Toronto
 2014-01 PHASE2
NCT02259647 COMPLETED
Hepatocellular Carcinoma
Institute of Liver and Biliary Sciences, India
 2014-10-01
NCT00990158 COMPLETED
Coagulation; Bleeding; Thrombosis
St. Joseph's Healthcare Hamilton
 2010-07 PHASE3
NCT01763307 COMPLETED
Rash Due to Epidermal Growth Factor Receptor Inhibitors
Hadassah Medical Organization
 2013-01 PHASE2
NCT01763307 Completed
Rash Due to Epidermal Growth Factor Receptor Inhibitors
Hadassah Medical Organization
 2013-01 Phase 2
NCT01638182 COMPLETED
Bone Health; Vascular Health
Maastricht University Medical Center
 2011-03
NCT01235325 COMPLETED
Supplementation; Bone Health; Crohn's Disease
University College Cork
 2008-07 PHASE4
NCT00794755 COMPLETED
Coagulation
Ottawa Hospital Research Institute
 2008-11 PHASE3
NCT01194778 COMPLETED
Carboxylation Level; Vitamin K-dependent Proteins
Maastricht University Medical Center
 2009-10
NCT00143715 COMPLETED
Coagulation; Bleeding; Thrombosis
St. Joseph's Healthcare Hamilton
 2004-09 PHASE3
NCT00150969 COMPLETED
Post-Menopausal Osteoporosis; Post-Menopausal Osteopenia
University Health Network, Toronto
 2002-01 PHASE3
NCT02256813 COMPLETED
Healthy
Boehringer Ingelheim
 2005-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-08-13)

Check the Vitamin K1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vitamin K1 functions as an essential cofactor for gamma-glutamyl carboxylase, driving the post-translational gamma-carboxylation of specific glutamic acid residues on precursor clotting factors and metabolic proteins. This biochemical modification enables calcium-dependent phospholipid membrane binding and protein activation, thereby restoring effective hemostasis and addressing clinical conditions such as coagulation deficits, vascular calcification, and epidermal growth factor receptor inhibitor-associated skin toxicity.

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.