CLINICAL TRIALS PROFILE FOR PHYTONADIONE

All Clinical Trials for phytonadione

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02324686 ↗	Vitamin K Supplementation in Patients on Hemodialysis	Completed	University Health Network, Toronto	Phase 2	2014-01-01	The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Kingston General Hospital	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Dr. Rachel Holden	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT01474460 ↗	Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy	Completed	James A. Haley Veterans Administration Hospital	N/A	2011-09-01	Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy. Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled. Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.
NCT00905229 ↗	Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-05-01	It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment. Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.

Clinical Trial Conditions for phytonadione

Condition Name

Condition Name for phytonadione
Intervention	Trials
Atrial Fibrillation	2
Complications	1
End Stage Renal Failure on Dialysis	1
End-stage Kidney Disease	1

Condition MeSH

Condition MeSH for phytonadione
Intervention	Trials
Atrial Fibrillation	2
Kidney Failure, Chronic	2
Kidney Diseases	1
Coronary Artery Disease	1

Clinical Trial Locations for phytonadione

Trials by Country

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Trials by Country for phytonadione
Location	Trials
Australia	4
United States	2
Canada	2
New Zealand	1
Israel	1

Trials by US State

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−

Trials by US State for phytonadione
Location	Trials
Michigan	1
Florida	1

Clinical Trial Progress for phytonadione

Clinical Trial Phase

Clinical Trial Phase for phytonadione
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for phytonadione
Clinical Trial Phase	Trials
Completed	4
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for phytonadione

Sponsor Name

Sponsor Name for phytonadione
Sponsor	Trials
University of Sydney	1
James A. Haley Veterans Administration Hospital	1
Kingston General Hospital	1

Sponsor Type

Sponsor Type for phytonadione
Sponsor	Trials
Other	11
U.S. Fed	1

Phytonadione: Clinical Trials, Market Analysis, and Projections

Introduction to Phytonadione

Phytonadione, also known as vitamin K1, is a vital nutrient that plays a crucial role in blood clotting and bone health. It is naturally found in green leafy vegetables and is also available as a dietary supplement and a pharmaceutical agent. Here, we will delve into the recent clinical trials, market analysis, and future projections for phytonadione.

Clinical Trials Update

Phase 2 Trial in Calciphylaxis

One of the significant clinical trials involving phytonadione is the phase 2 randomized controlled trial (RCT) conducted to evaluate its efficacy in patients with calciphylaxis. Calciphylaxis is a rare and life-threatening disorder characterized by the calcification of cutaneous microvessels, leading to painful skin lesions. There are no approved therapies for this condition, and vitamin K deficiency is implicated due to its role in the gamma-carboxylation of matrix Gla protein (MGP), a calcification inhibitor.

In this trial, adult hemodialysis patients with calciphylaxis were randomly assigned to receive either oral phytonadione 10 mg or a placebo three times a week for 12 weeks. The results showed a significant reduction in uncarboxylated MGP levels in the phytonadione group compared to the placebo group. Additionally, phytonadione treatment resulted in greater improvements in the size of skin lesions and pain intensity. Notably, the mortality rate at 12 weeks was 0% in the phytonadione group versus 31% in the placebo group, highlighting the potential clinical efficacy of phytonadione in managing calciphylaxis[1].

Anticoagulation Management

Another important clinical context for phytonadione is its use in managing excessive anticoagulation. A randomized, double-blind, placebo-controlled study investigated the efficacy of oral phytonadione in reducing international normalized ratios (INRs) in patients with INRs ranging from 6.0 to 10.0. The study found that adding oral phytonadione 2.5 mg to omitting warfarin therapy reduced the time to achieve an INR of 4.0 by approximately one day compared to omitting warfarin alone. This suggests that phytonadione can be an effective strategy for managing asymptomatic patients with elevated INRs, particularly those at high risk for bleeding[4].

Market Analysis

Global Market Size and Growth

The global vitamin K market, which includes phytonadione, has been experiencing significant growth. In 2023, the global market size was estimated to be around USD 918.94 million and is projected to reach USD 2,126.08 million by 2033, growing at a compound annual growth rate (CAGR) of 8.75% from 2024 to 2033[2].

Segment Analysis

The vitamin K market can be segmented by product type, route of administration, and application. The vitamin K1 segment, which includes phytonadione, is expected to grow at a CAGR of 8.2% from 2023 to 2032, driven by its increasing use in diet supplements and its role in treating blood clotting disorders and improving bone health[5].

Regional Market

The U.S. vitamin K market is a significant contributor to the global market. In 2023, the U.S. market size was USD 250.87 million and is anticipated to grow to USD 580.42 million by 2033. The North American region, particularly the U.S., dominates the anticoagulant reversal drugs market, where phytonadione holds a major market share due to its essential role in managing bleeding events associated with vitamin K-dependent anticoagulants[2][3].

Drivers and Trends

The increasing prevalence of chronic disorders such as osteoporosis, cardiovascular diseases, and coagulation disorders is driving the demand for vitamin K, including phytonadione. The growing burden of osteoporosis, for instance, has led to a higher intake of vitamin K supplements to reduce the risk of bone fractures. Additionally, the rising use of anticoagulants and the need for their reversal agents further bolster the demand for phytonadione[2][5].

Market Projections

Future Growth

The vitamin K market, including phytonadione, is expected to continue its upward trend. The global market is projected to grow at a CAGR of 8.75% from 2024 to 2033, driven by the increasing awareness among healthcare professionals and the growing need for anticoagulation management solutions. The U.S. market is anticipated to grow significantly, reaching USD 580.42 million by 2033[2].

Application-Specific Growth

The osteoporosis application segment is expected to be a major driver of the vitamin K market. With nearly 10 million people aged 50 and above in the U.S. suffering from osteoporosis, the demand for vitamin K supplements to improve bone density and reduce fracture risks is likely to increase[5].

Regulatory and Research Support

Regulatory support and rigorous clinical research are expected to contribute to the swift adoption of new reversal agents, including phytonadione. Strategic collaborations between pharmaceutical companies and research institutions will continue to foster innovation in this critical healthcare segment[3].

Key Takeaways

• Clinical Efficacy: Phytonadione has shown promising results in clinical trials, particularly in managing calciphylaxis and reducing INRs in patients with excessive anticoagulation.
• Market Growth: The global vitamin K market, including phytonadione, is projected to grow significantly, driven by the increasing prevalence of chronic disorders and the need for anticoagulation management.
• Regional Dominance: The U.S. market is expected to remain a major contributor to the global vitamin K market, driven by its robust healthcare infrastructure and growing awareness among healthcare professionals.
• Application-Specific Demand: The demand for phytonadione is expected to increase in applications such as osteoporosis and anticoagulant reversal.

FAQs

What is phytonadione used for?

Phytonadione, or vitamin K1, is used for various medical applications, including the treatment of blood clotting disorders, managing excessive anticoagulation, and improving bone health.

What are the key findings of the phase 2 trial of phytonadione in calciphylaxis?

The phase 2 trial showed that oral phytonadione reduced uncarboxylated MGP levels, improved skin lesion size and pain intensity, and had a lower mortality rate compared to the placebo group.

How is the global vitamin K market expected to grow?

The global vitamin K market is projected to grow at a CAGR of 8.75% from 2024 to 2033, reaching USD 2,126.08 million by 2033.

What drives the demand for phytonadione in the U.S. market?

The demand for phytonadione in the U.S. is driven by the increasing prevalence of chronic disorders, the need for anticoagulation management solutions, and the robust healthcare infrastructure.

What are the potential risks associated with phytonadione treatment?

While phytonadione is generally safe, one patient in the calciphylaxis trial developed hepatic thrombosis, and there is a risk of overcorrection of anticoagulation, which can lead to thromboembolic complications[1][4].

Sources

1. American Society of Nephrology, "Phase 2 Trial of Phytonadione in Calciphylaxis," Kidney Week, November 07, 2019.
2. Precedence Research, "Vitamin K Market Size, Share, and Trends 2024 to 2033."
3. Cognitive Market Research, "Anticoagulant Reversal Drugs Market Report 2024 (Global Edition)."
4. PubMed, "Randomized, placebo-controlled trial of oral phytonadione for excessive anticoagulation."
5. GMI Insights, "Vitamin K Market Projections | Industry Size Report, 2023-2032."