Vitamin K1

Generic Name: Vitamin K1

Brand Names: Aquamephyton, Infuvite, Infuvite Pediatric, Mephyton, Mvi Pediatric, Phytonadione

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₄₆O_₂

CAS Number: 84-80-0

Unique Ingredient Identifier: S5Z3U87QHF

Background: Vitamin K1, also called phylloquinone or phytonadione, is a fat soluble vitamin. Phylloquinone is a cofactor of the enzyme γ-carboxylase, which modifies and activates precursors to coagulation factors II, VII, IX, and X. It is indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K.

Phylloquinone has been synthesized since at least 1939, and was approved by the FDA prior to 1955.

Indication: Oral phylloquinone is indicated to treat prothrombin deficiency caused by coumarin or indanedione derivatives; and hypoprothrombinemia secondary to antibacterial therapy, salicylates, or obstructive jaundice or biliary fistulas with concomitant bile salt administration.

Parenteral (intravenous, intramuscular, and subcutaneous) phylloquinone is indicated to treat coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by vitamin K deficiency or some interference with vitamin K activity. These indications include the above indications as well as hypoprothrombinemia secondary to sprue, ulcerative colitis, celiac disease, intestinal resection, pancreatic cystic fibrosis, or regional enteritis; or hypoprothrombinemia caused by interference with vitamin k metabolism.

Associated Conditions: Coagulation Disorder, Hypoprothrombinemia, Hemorrhagic disease of the newborn

Associated Therapies: Vitamin supplementation

Clinical Trials

Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding

Phase 4

Completed

Conditions: Variceal Bleeding

Interventions: Drug: Vitamin K1

First Posted Date: 2025-02-21

Last Posted Date: 2025-02-21

Lead Sponsor: Zagazig University

Target Recruit Count: 66

Registration Number: NCT06839352

Locations: 🇪🇬
Zagazig University Hospital, Zagazig, Sharkia, Egypt

Prevention of Cefoperazone-induced Coagulopathy

Phase 4

Completed

Conditions: Antibiotic Side Effect

Interventions: Drug: Vitamin K

First Posted Date: 2023-02-23

Last Posted Date: 2023-10-10

Lead Sponsor: Helwan University

Target Recruit Count: 56

Registration Number: NCT05742295

Locations: 🇪🇬
6-October Hospital, Giza, Egypt

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: SHR0302 Tablets
Drug: Midazolam Maleate Tablets
Drug: Warfarin Sodium Tablets
Drug: Omeprazole Enteric Capsules
Drug: Vitamin K1 Tablets
Drug: Repaglinide Tablets

First Posted Date: 2022-05-26

Last Posted Date: 2022-12-22

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 24

Registration Number: NCT05392127

Locations: 🇨🇳
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

Phase 1

Completed

Conditions: Chronic Hepatitis B

Interventions: Drug: HRS5091 Tablets
Drug: Midazolam Maleate Tablets
Drug: Warfarin Sodium Tablets
Drug: Omeprazole Enteric Capsules
Drug: Vitamin K1 Tablets
Drug: Digoxin Tablets
Drug: Rosuvastatin Calcium Tablets

First Posted Date: 2022-03-10

Last Posted Date: 2022-12-23

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 22

Registration Number: NCT05273775

Locations: 🇨🇳
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Better Evidence and Translation for Calciphylaxis

Phase 3

Recruiting

Conditions: Calciphylaxis

Interventions: Drug: Sodium Thiosulfate
Device: Medium Cut-off Dialyser
Device: High Flux Dialyser
Drug: Vitamin K1
Drug: Magnesium citrate
Drug: Placebo capsule (Vitamin K1)
Drug: Placebo injection (normal saline)
Drug: Placebo tablet (Magnesium citrate)

First Posted Date: 2021-08-24

Last Posted Date: 2024-06-21

Lead Sponsor: University of Sydney

Target Recruit Count: 350

Registration Number: NCT05018221

Locations: 🇦🇺
Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇦🇺
Sunshine Hospital (Western Health), St Albans, Victoria, Australia
🇳🇿
Tauranga Hospital, Tauranga, New Zealand

and more 11 locations

Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients

Phase 2

Completed

Conditions: End Stage Renal Disease on Dialysis

Interventions: Other: placebo
Drug: Vitamin K1
Drug: Vitamin k2

First Posted Date: 2020-07-20

Last Posted Date: 2021-07-21

Lead Sponsor: Ain Shams University

Target Recruit Count: 40

Registration Number: NCT04477811

Locations: 🇪🇬
Ainshams University, Cairo, Egypt

Effects of Fhytomenadione on Coronary Artery Calcification of Hemodialysis Patients

Not Applicable

Completed

Conditions: Coronary Calcification

Interventions: Drug: placebo solution
Drug: phytomenadione

First Posted Date: 2020-01-29

Last Posted Date: 2020-01-29

Lead Sponsor: Instituto Mexicano del Seguro Social

Target Recruit Count: 60

Registration Number: NCT04247087

Locations: 🇲🇽
Hospital de Alta Especialidad No. 1 Bajío, Boulevard Adolfo López Mateos esquina Insurgentes S/N, colonia Los Paraísos, Leon, Guanajuato, Mexico

Comparison of Vitamin K Doses in Patients With Larger Burn Injuries

Phase 4

Conditions: Burns

Interventions: Drug: Vitamin K

First Posted Date: 2019-05-08

Last Posted Date: 2021-08-25

Lead Sponsor: Joseph M. Still Research Foundation, Inc.

Target Recruit Count: 50

Registration Number: NCT03941535

Locations: 🇺🇸
Joseph M. Still Burn Center at Doctors Hospital, Augusta, Georgia, United States

Effect of Vitamin K in Critically Ill Patients

Completed

Conditions: Vitamin K Deficiency
Coagulopathy, Consumption
Coagulation Factor Deficiency

Interventions: Drug: Phytomenadione

First Posted Date: 2018-12-20

Last Posted Date: 2021-03-18

Lead Sponsor: Region Skane

Target Recruit Count: 52

Registration Number: NCT03782025

Locations: 🇸🇪
Skåne University Hospital, Lund, Skåne, Sweden
🇸🇪
Intensive and perioperative care. Skåne University Hospital. Lund, Lund, Skåne, Sweden

Vitamin K1 in the Treatment of Spontaneous Intracerebral Hemorrhage

Early Phase 1

Conditions: Intracerebral Haemorrhage in Cerebellum

Interventions: Drug: normal saline
Drug: Vitamin K 1

First Posted Date: 2018-01-03

Last Posted Date: 2018-01-04

Lead Sponsor: HUANG XIANJIAN

Target Recruit Count: 400

Registration Number: NCT03388970

Locations: 🇨🇳
The fifth people's hospital of Longgang District, Shenzhen, Shenzhen, Guangdong, China
🇨🇳
Baoan District central hospital of Shenzhen, Shenzhen, Guangdong, China
🇨🇳
Shajing hospital of Baoan District ,Shenzhen, Shenzhen, Guangdong, China

and more 2 locations

Drug Development Updates

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