The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,
The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.

Start Date03 Jun 2025

Sponsor / Collaborator

Boston University

CTR20241899

/ RecruitingPhase 1/2

评价K1注射液联合替莫唑胺和放疗治疗经标准治疗失败的高级别脑胶质瘤患者和初治Ⅳ级脑胶质瘤患者的安全性、耐受性和有效性的Ib/IIa期研究

[Translation] A phase Ib/IIa study to evaluate the safety, tolerability and efficacy of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment and patients with newly diagnosed grade IV glioma

Ib期剂量递增阶段主要目的： a. 评价K1注射液联合替莫唑胺和放疗治疗经标准治疗失败的高级别脑胶质瘤患者的安全性、耐受性； b. 确定Ⅱa期K1注射液联合治疗的OBD (Optimal Biological Dose，最优生物剂量）。次要目的： a. 评价K1注射液联合替莫唑胺和放疗治疗在经标准治疗失败的高级别脑胶质瘤患者中的药代动力学特征、药效动力学特征和免疫原性； b. 初步评价K1注射液联合替莫唑胺和放疗治疗经标准治疗失败的高级别脑胶质瘤患者的初步有效性。探索性目的：探索生物标志物（ASS1表达）与抗肿瘤活性的关系。 IIa期剂量扩展阶段主要目的：评估K1注射液联合替莫唑胺和放疗治疗初治Ⅳ级脑胶质瘤患者的初步有效性。次要目的： a. 评价K1注射液联合替莫唑胺和放疗治疗初治Ⅳ级脑胶质瘤患者的安全性、耐受性； b. 评价K1注射液联合替莫唑胺和放疗治疗在初治Ⅳ级脑胶质瘤患者中的药代动力学特征、药效动力学特征和免疫原性。探索性目的：探索生物标志物（ASS1表达）与抗肿瘤活性的关系。

[Translation]

Phase Ib dose escalation phase Main objectives: a. To evaluate the safety and tolerability of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment; b. To determine the OBD (Optimal Biological Dose) of K1 injection combined therapy in Phase IIa. Secondary objectives: a. To evaluate the pharmacokinetic, pharmacodynamic and immunogenicity of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment; b. To preliminarily evaluate the preliminary efficacy of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment. Exploratory objectives: To explore the relationship between biomarkers (ASS1 expression) and anti-tumor activity. Phase IIa dose expansion phase Main objectives: To evaluate the preliminary efficacy of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma. Secondary objectives: a. To evaluate the safety and tolerability of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma; b. To evaluate the pharmacokinetic, pharmacodynamic and immunogenicity of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma. Exploratory objectives: To explore the relationship between biomarkers (ASS1 expression) and anti-tumor activity.

Start Date26 Aug 2024

Sponsor / Collaborator

Jiangsu Kanghe Biopharmaceutical Co., Ltd.

CTR20220671

/ CompletedPhase 1

评估K1注射液在晚期实体瘤患者中的耐受性、安全性及药代动力学和初步疗效的I期临床研究

[Translation] A Phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of K1 injection in patients with advanced solid tumors

主要目的评价K1注射液的安全性，指标为不良事件（AE）、严重不良事件（SAE）、最大耐受剂量（MTD）、剂量限制性毒性（DLT）、合理的给药方案、确定后续临床试验推荐的给药方案。次要目的评价K1注射液人体药代动力学特征，获取初步药代动力学参数，进行可能的药代动力学／药效动力学（PK/PD）分析。同时评价K1注射液的免疫原性；初步评价K1注射液的临床疗效；为后期临床试验的给药方案提供支持依据。

[Translation]

Main purpose Evaluate the safety of K1 injection, with indicators of adverse events (AE), serious adverse events (SAE), maximum tolerated dose (MTD), dose-limiting toxicity (DLT), reasonable dosing regimen, and determine the recommended dosing regimen for subsequent clinical trials. Secondary purpose Evaluate the pharmacokinetic characteristics of K1 injection in humans, obtain preliminary pharmacokinetic parameters, and conduct possible pharmacokinetic/pharmacodynamic (PK/PD) analysis. At the same time, evaluate the immunogenicity of K1 injection; preliminarily evaluate the clinical efficacy of K1 injection; and provide support for the dosing regimen of later clinical trials.

Start Date22 Jun 2022

Sponsor / Collaborator

Jiangsu Kanghe Biopharmaceutical Co., Ltd.

100 Clinical Results associated with K-1

100 Translational Medicine associated with K-1

100 Patents (Medical) associated with K-1

Literatures (Medical) associated with K-1

01 Nov 2025·AMERICAN JOURNAL OF CLINICAL NUTRITION

Impact of sustainable diets on micronutrient intakes and status: outcomes of the MyPlanetDiet randomized controlled trial

Article

Author: Kiely, Mairead E ; McCarthy, Sinead N ; Nugent, Anne P ; Gibney, Eileen R ; Lindberg, Leona ; Woodside, Jayne V ; Arranz, Elena ; Davies, Katie P ; O'Sullivan, Aifric M ; Leonard, Ursula M

BACKGROUND:

Data from dietary intervention studies to test the ability of sustainable diets to meet micronutrient (MN) requirements is required.

OBJECTIVES:

To compare MN intakes and status among adults who received dietary counseling to follow a sustainable diet or a standard healthy diet.

METHODS:

We conducted a single-blind, randomized controlled trial among 355 healthy adults aged 18‒64 y in 3 centers over 12-wk. Participants received personalized dietary counseling; the intervention arm for a sustainable healthy diet, and the control arm for a healthy diet. Greenhouse gas emissions (GHGEs), MNs, and biomarkers of nutritional status were assessed, and the prevalence of inadequate intakes was defined by the proportion of participants with usual intakes below harmonized average requirements. Data were analyzed using a 2-way mixed analysis of covariance (time and treatment) on complete cases.

RESULTS:

There were differential changes in intakes in the intervention arm compared to controls for GHGE (‒22%), energy (‒8%), retinol (‒25%), thiamin (‒11%), riboflavin (‒16%), niacin (‒16%), calcium (‒16%), zinc (‒13%), potassium (‒10%), selenium (‒15%), and iodine (‒26%), vitamins B₆ (‒12%), vitamin B₁₂ (‒36%), vitamin C (‒23%), vitamin D (‒28%) and vitamin K₁ (30%) (P-_interaction < 0.05). These were consistent following energy adjustment for retinol, riboflavin, niacin, calcium, iodine, and vitamins B₁₂ and K_1. The prevalence of inadequate intakes of riboflavin, vitamins B₆ and B₁₂, calcium, and zinc increased considerably, and at the endpoint, there was a higher prevalence of inadequate intakes in the intervention arm for riboflavin, vitamins B₆, B₁₂, and C, calcium, zinc, and selenium than in controls. Iron, iodine, vitamins A, D, E, C, and K₁ status did not change.

CONCLUSIONS:

A diet based on sustainable dietary principles lowered dietary GHGE and several MNs, despite the provision of daily servings of dairy, 3 weekly servings of animal protein, and 2 servings of fish. These findings show that MNs should be considered in developing environmentally protective diets. This trial was registered at clinicaltrials.gov as NCT05253547.

01 Jul 2025·Journal of Cystic Fibrosis

Dietary intakes and quality of Irish adults with cystic fibrosis: Comparisons to nutrition guidelines and HEI-2020

Article

Author: Connolly, Mary ; O'Brien, Lauren ; Whiston, Aoife ; Cronin, Karen ; O'Sullivan, Derbhla ; Tecklenborg, Sarah ; Tierney, Audrey ; Robinson, Katie ; Greaney, Cian ; McCarthy, Ellen ; Howlett, Ciara ; Landers, Clodagh

BACKGROUND:

With evolving Cystic Fibrosis (CF) phenotypes resulting from changes to clinical management, healthier dietary practices are warranted for many people with CF. Whilst diet composition is reported, diet quality data is lacking in CF. This study aims to evaluate dietary intakes and diet quality in adults with CF via guideline comparison and a validated diet quality index.

METHODS:

Cross-sectional study of Irish adults with CF. Demographic questionnaires and three-day food diaries were completed. Healthy Eating Index - 2020 (HEI-2020) assessed diet quality. Data was statistically analysed in SPSS®.

RESULTS:

Of n = 68 participants (female: 58.8 %, age: 35.2 ± 10.1 years, FEV₁%: 77.4 ± 25.1 %), 36.8 % were overweight/obese and 77.6 % pancreatic insufficient. While median (interquartile range) percentage estimated average requirement (EAR) was 110.1 (45.3) %, 50.0 % of participants were below CF energy requirements (110 % EAR). Mean percentage total energy intake (%TEI) protein (18.0 ± 3.9 %) aligned to dietary reference values (DRV). %TEI carbohydrates (44.1 ± 6.5 %) was below, and %TEI fat (37.1 ± 5.4 %), saturated fat (14.1 ± 3.3 %) and sugar (17.4 ± 5.6 %) exceeded DRV. Median vitamin A intake was adequate [936.6 (1005.2) µg], but vitamin D [3.6 (4.3) µg], E (9.6 ± 5.2 mg) and K₁ [31.1 (71.2) µg] intakes were insufficient without supplementation. Regarding Irish healthy eating guidelines, 95.6 % of participants overconsumed energy-dense nutrient poor (EDNP) foods, with 76.5 % below vegetables, salad and fruit intake guidelines. Participants' mean HEI-2020 score (0-100) was 59.3 ± 12.4.

CONCLUSION:

Findings indicate suboptimal diet quality. Despite reliance on EDNP foods, many did not achieve energy targets. Moving forward, emphasis on diet quality is of paramount importance to improve overall health in people with CF.

01 May 2025·JOURNAL OF PHARMACEUTICAL SCIENCES

Ezetimibe alters micelle structure and reduces Niemann-Pick C1-like 1-mediated absorption of vitamins E and K1 in CaCo-2 cells

Article

Author: Aizawa, Hideki

Ezetimibe (EZE) is known to inhibit cholesterol absorption by targeting Niemann-Pick C1-like 1 (NPC1L1). However, its effects on the absorption of fat-soluble vitamins, such as Vitamin E and Vitamin K₁, remain unclear. This study investigates how EZE impacts micellar properties and vitamin absorption. We analyzed the shape, size, diffusion rate, and zeta-potential of micelles during Vitamin E and K₁ absorption. Our findings demonstrate that EZE causes micelles to transition from an elliptical to a cylindrical shape, reducing vitamin absorption efficiency. EZE also impairs absorption by altering micelle composition, hindering NPC1L1 binding, and directly blocking vitamin uptake. EZE negatively affects Vitamin E and K₁ absorption, raising concerns about potential deficiencies with long-term use. These findings highlight the need for strategies to minimize the adverse effects of EZE in clinical practice.

100 Deals associated with K-1

External Link

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
High grade glioma	Phase 2	China	Jiangsu Kanghe Biopharmaceutical Co., Ltd.	26 Aug 2024
Advanced Malignant Solid Neoplasm	Phase 1	China	Jiangsu Kanghe Biopharmaceutical Co., Ltd.	22 Jun 2022
Liver Cancer	Phase 1	China	Jiangsu Kanghe Biopharmaceutical Co., Ltd.	22 Jun 2022
Malignant Pleural Mesothelioma	IND Approval	China	Jiangsu Kanghe Biopharmaceutical Co., Ltd.	28 Sep 2023
Soft Tissue Sarcoma	IND Approval	China	Jiangsu Kanghe Biopharmaceutical Co., Ltd.	27 Sep 2023

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