A Non-inferiority, Randomized Double-blind Controlled Clinical Trial Comparing the Effect of Vitamin D Supplementation Derived From Fish Waste Versus Synthetic Vitamin D on Plasma Vitamin D Levels and Anthropometric and Laboratory Correlates in Healthy Subjects With Suboptimal Blood Vitamin D Levels

Vitamin D is a fat-soluble vitamin with hormone-like properties, essential for numerous physiological processes in humans. It plays a central role in maintaining calcium and phosphorus homeostasis, promoting intestinal absorption of these minerals, and ensuring optimal bone mineralization. There are two main forms: vitamin D2 (ergocalciferol), primarily obtained from plant sources and supplements, and vitamin D3 (cholecalciferol), synthesized endogenously in the skin through exposure to ultraviolet B (UVB) radiation and present in animal-derived foods such as fatty fish, liver, and egg yolks. Beyond its well-known skeletal functions, vitamin D contributes to muscle contraction, immune system modulation, and regulation of cell proliferation and differentiation. Increasing evidence suggests that adequate vitamin D status may benefit cardiovascular health, glucose metabolism, and possibly reduce the risk of certain cancers, while supplementation has been associated with improved plasma lipid profiles, a relevant factor in cardiovascular risk reduction. The European Food Safety Authority has authorized various health claims for vitamin D, including its role in normal calcium and phosphorus absorption and utilization, maintenance of normal blood calcium concentrations, bone and teeth health, normal muscle function, immune defense, and reduction of the risk of falls in older adults. Despite its importance, vitamin D deficiency is recognized as a widespread public health concern across Europe, with prevalence influenced by latitude, season, skin pigmentation, and lifestyle habits. Data indicate that up to 40% of Europeans have suboptimal vitamin D levels, with deficiency rates exceeding 70% in specific high-risk groups such as elderly individuals, people with dark skin, and those with limited sun exposure. In Italy, despite abundant sunlight, vitamin D insufficiency is highly prevalent, particularly in older adults and patients with chronic illnesses. Contributing factors include urbanization, sedentary lifestyles, reduced time spent outdoors, and cultural or clothing practices limiting sun exposure. Approximately half of the Italian population is estimated to have insufficient vitamin D levels, with rates rising in the northern regions during winter months. Prolonged deficiency has severe consequences for skeletal health, including rickets in children, osteomalacia in adults, and increased risk of osteoporosis and fractures. It is also linked to a broad range of extra-skeletal effects, such as impaired immune response with greater susceptibility to infections, increased risk of chronic diseases including cardiovascular disorders, type 2 diabetes, and certain cancers, as well as muscle weakness, higher likelihood of falls, and mood disorders such as depression and seasonal affective disorder. Addressing vitamin D deficiency requires a multifaceted approach involving dietary supplementation, food fortification strategies, and public health initiatives promoting safe sunlight exposure. Severe deficiency requires pharmacological treatment with appropriately dosed medications, whereas mild deficiency can be corrected through over-the-counter supplements. In Italy, vitamin D supplements contain up to 2000 IU per day, with the recommended daily allowance for healthy adults set at 600 IU. The demand for vitamin D supplementation is reflected in market trends: the global market was valued at USD 1.69 billion in 2022 and is projected to reach USD 3.44 billion by 2031, with an estimated compound annual growth rate of 8.22% between 2023 and 2031. Against this background, the exploration of natural, sustainable sources of vitamin D, particularly from food industry by-products such as fish waste, offers an environmentally friendly alternative to synthetic forms currently dominating the market. This concept underpins the PRIN research project "Innovative and sustainable processes for the development of Vitamin D nutraceutical from fish waste: extraction, formulation and clinical study for the evaluation of its bioavailability and clinical consequence" (VITADWASTE; 2022M9JL3%; National Coordinator: Prof. Gianni Sagratini, University of Camerino), supported by the Italian Ministry of University. The project aims to develop and clinically evaluate a fish-derived vitamin D nutraceutical as a sustainable solution. Within this context, the primary objective of the present randomized, double-blind, non-inferiority clinical trial is to assess whether supplementation with fish-derived vitamin D at a dose of 600 IU per day, corresponding to 100% of the recommended daily intake for healthy adults, has an effect on plasma vitamin D levels comparable to that of an equivalent dose of standard synthetic vitamin D in healthy adults with mild vitamin D deficiency, defined by plasma concentrations between 20 and 40 ng/mL.

开始日期2025-09-01

申办/合作机构

Alma Mater Studiorum - Università di Bologna

NCT07081776

/ Not yet recruitingN/AIIT

Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe Exacerbation of COPD Requiring Non-Invasive Mechanical Ventilation: A Single-Center, Exploratory, Randomized Cross-Over Study

This single-center, crossover study aims to investigate the effects of the new OptiNIV oronasal mask used during NIV in COPD patients with respiratory acidosis following an exacerbation. The goal is to evaluate whether the clinical benefits, in terms of reducing PaCO2 levels, are greater with the new mask compared to a traditional one (Visairo Mask).

开始日期2025-08-01

申办/合作机构

IRCCS Azienda Ospedaliero-Universitaria di Bologna

[+2]

NCT07041060

/ CompletedN/AIIT

Evaluation of the Efficacy and Safety of a Nutraceutical Containing Sodium Alginate, Sodium Bicarbonate, PEA, a Blend of Opuntia Ficus Indica, and Olea Europaea, Musa Paradisiaca, and Ginger in Patients With NERD

Background: Non-erosive reflux disease (NERD) is a prevalent subtype of gastroesophageal reflux disease (GERD), often inadequately managed with proton pump inhibitors (PPIs) alone. Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts, has been proposed as an adjunctive therapy to enhance symptom relief and mucosal protection.
Objective: This study evaluates the efficacy and safety of a nutraceutical [Eolo®, Cristalfarma s.r.l. - Milan (IT)] in combination with PPIs or alone compared to PPIs therapy in patients with NERD.
Methods: A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).

开始日期2025-05-30

申办/合作机构

Alma Mater Studiorum - Università di Bologna

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项与 Alma Mater Studiorum - Università di Bologna 相关的文献（医药）

2025-12-31·Gut Microbes

Lactiplantibacillus plantarum (CECT7484 and CECT7485) and Pedioccoccus acidilactici (CECT7483) enhance actin cytoskeleton and CYP1A1 expression restoring epithelial permeability alterations induced by irritable bowel syndrome mediators

Article

作者: Perez, Marta ; Espadaler-Mazo, Jordi ; Guglielmetti, Simone ; Stanghellini, Vincenzo ; Barbaro, Maria Raffaella ; Barbara, Giovanni ; Marasco, Giovanni ; Cremon, Cesare ; Palombo, Marta ; Bianco, Francesca ; Bonomini, Francesca ; Delprete, Cecilia

Irritable bowel syndrome (IBS) is a multifactorial condition with heterogeneous pathophysiology, including intestinal permeability alterations. The aim of the present study was to assess the ability of a probiotic blend (PB) consisting of two Lactiplantibacillus plantarum strains (CECT7484 and CECT7485) and one strain of Pediococcus acidilactici (CECT7483) to recover the permeability increase induced by mediators from IBS mucosal biopsies and to highlight the underlying molecular mechanisms. Twenty-one IBS patients diagnosed according to ROME IV criteria (11 IBS-D and 10 IBS-M) and 7 healthy controls were enrolled. Mucosal mediators spontaneously released by IBS and HC biopsies were collected and incubated with/without the PB (10⁴ and 10⁶ CFU/ml). Paracellular permeability was assessed by evaluating the amount of sulfonic-acid-conjugated to fluorescein passing through the Caco-2 monolayer. RNA was extracted from Caco-2 cells and used to perform qPCR analyses, to evaluate the expression of ZO-1 and β-actin, and RNAseq to evaluate the transcriptomic profile. Untargeted metabolomics was used to characterize metabolites produced by the PB. The PB significantly reduced paracellular permeability after 3 h of incubation. Both doses of the PB significantly recovered the increase in paracellular permeability induced by IBS mediators. qPCR analyses showed that both doses of the PB co-incubated with IBS mediators induced a significant increase in beta-actin expression compared to IBS mediators alone. Concerning IBS subtypes, the high dose of the PB recovered the increase of permeability induced by IBS-D mediators. Transcriptomic analyses, confirmed by qPCR, showed that the high dose of the PB significantly increased CYP1A1 compared to IBS mediators alone. The PB produced a high amount of indole-3-lactic acid. The PB recovers the permeability increase induced by IBS mediators inducing the up-regulation of β-actin. In addition, the PB up-regulates the expression of CYP1A1, known to be involved in the metabolism of xenobiotics, possibly through the production of the indole-3-lactic acid.

2025-12-31·Artificial Cells Nanomedicine and Biotechnology

Article

作者: Ciardulli, Maria Camilla ; Giordano, Emanuele ; Maffulli, Nicola ; Forsyth, Nicholas R. ; Della Porta, Giovanna ; Lovecchio, Joseph ; Clerici, Marta ; Lamparelli, Erwin Pavel ; Dale, Tina P.

Tendon injuries significantly impact quality of life, prompting the exploration of innovative solutions beyond conventional surgery. Extracellular Vesicles (EVs) have emerged as a promising strategy to enhance tendon regeneration. In this study, human Tendon Stem/Progenitor Cells (TSPCs) were isolated from surgical biopsies and cultured in a Growth-Differentiation Factor-5-supplemented medium to promote tenogenic differentiation under static and dynamic conditions using a custom-made perfusion bioreactor. Once at 80% confluence, cells were transitioned to a serum-free medium for conditioned media collection. Ultracentrifugation revealed the presence of vesicles with a 10⁶ particles/mL concentration and sub-200nm diameter size. Dynamic culture yielded a 3-fold increase in EV protein content compared to static culture, as confirmed by Western-blot analysis. Differences in surface marker expression were also shown by flow cytometric analysis. Data suggest that we efficiently developed a protocol for extracting EVs from human TSPCs, particularly under dynamic conditions. This approach enhances EV protein content, offering potential therapeutic benefits for tendon regeneration. However, further research is needed to fully understand the role of EVs in tendon regeneration.

2025-12-31·Human Vaccines & Immunotherapeutics

Review

作者: Marchetti, Andrea ; Mollica, Veronica ; Piazza, Pietro ; Mottaran, Angelo ; Rosellini, Matteo ; Danielli, Linda ; Ricci, Costantino ; Tassinari, Elisa ; Schiavina, Riccardo ; Massari, Francesco ; Santoni, Matteo

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC's scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.

项与 Alma Mater Studiorum - Università di Bologna 相关的新闻（医药）

2025-07-09

·PRNewswire

GORE ANNOUNCES MDR EXPANDED INDICATION FOR THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AS A BRIDGING STENT

The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis indication expansion brings the first bridging stent device with dual indication for both fenestrated and branched endovascular repair*. PUTZBRUNN, Germany, July 9, 2025 /PRNewswire/ -- W. L. Gore & Associates (Gore) announces CE Mark approval of an expanded indication for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) when used as a bridging stent with branched and fenestrated aortic endografts† in the treatment of aortic aneurysms involving the renal and mesenteric arteries. Continue Reading GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis "This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies," said Prof. Luca Bertoglio, Associate Professor, Vascular Surgery, Spedali Civili Brescia and Coordinating Investigator of the EMBRACE Registry. A total of 259 patients were enrolled in the study. High rates of patency and freedom from endoleaks, target vessel instability and reinterventions were observed with the VBX Stent Graft in both branched and fenestrated EVAR (bEVAR and fEVAR) cohorts at 1 year. "We have studied performance in both fenestrated and branched cohorts, and the results demonstrate that we can safely and effectively treat these patients with the VBX Device," Prof. Bertoglio added. This multicenter, retrospective and prospective registry was conducted to evaluate the clinical performance and safety of the VBX Stent Graft as a bridging stent. A total of 14 centers in Europe enrolled 259 patients who have had treatment with the VBX Stent Graft. These subjects will have prospective follow-up visits up to 5 years after the index procedure. "Physicians have waited some time for an approved bridging stent indication for fenestrated and branched repair. Having a CE-marked indication is very important, as it is certainly of relevance to the endovascular community and the eligible patient population," said Prof. Mauro Gargiulo, Chair of Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital, University of Bologna and Principal Investigator of the EXPAND1 Registry. "I applaud Gore for recognizing the need for a CE Mark indication and for being committed to conducting such thorough and expertly run clinical studies like EXPAND and EMBRACE." In the coming weeks, hospitals will start implanting the newly indicated VBX Stent Graft in fEVAR and bEVAR procedures. The official launch is planned after summer when many European and local congresses are taking place. The VBX Stent Graft offers precise delivery and supports positive outcomes in a variety of complex applications. The device was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59 and also 79 mm. It is currently the longest balloon expandable stent graft available, covering a wide variety of treatment needs. The VBX Stent Graft also offers the largest range of diameter adjustability in a single device, with a maximum post-dilated diameter of up to 16 mm with 8L or 11 mm devices.†,2-5 Additional information about the EMBRACE and EXPAND clinical studies is available at and EMBRACE and EXPAND Registries are part of Gore's dedication to research, fitness-for-use and long-term device performance in an effort to expand device indications, improve clinical practice and patient outcomes. Data will be representative of real-world, clinical use. Real-world clinical use data are integral for Gore, combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device performance in addition to any long-term clinical investigations as well as reports in medical journals and congress presentations. "This is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market. This announcement is the culmination of years of deep collaboration with physicians aimed at understanding and overcoming clinical and technical challenges in complex aortic repair," according to Jill Paine, leader of Gore's Peripheral Business. For more information about the VBX Stent Graft, visit goremedical.com/eu. Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com/eu. About Gore W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion. gore.com. 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2025-06-10

·PRNewswire

Foresight Diagnostics and Partners to Present Independent Validation Data for its CLARITY™ MRD Assay at the 2025 European Hematology Association (EHA) Congress and International Conference on Malignant Lymphoma (ICML)

- Data will be presented as an oral presentation at EHA on Thursday, June 12, 2025, and at ICML on Thursday, June 19, 2025 BOULDER, Colo., June 10, 2025 /PRNewswire/ -- Foresight Diagnostics, a leading developer of ultra-sensitive minimal residual disease (MRD) detection technologies, today announced that validation data demonstrating the prognostic performance of its CLARITY™ MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be featured as encore oral presentations at two upcoming international conferences: the 2025 European Hematology Association (EHA) Congress (June 12–15, in Milan, Italy) and the 18th International Conference on Malignant Lymphoma (ICML) (June 17–21, in Lugano, Switzerland). This multi-center study, conducted in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON), and the Netherlands Comprehensive Cancer Organization (IKNL), highlights real-world results using Foresight CLARITY™ MRD on patients who were treated with frontline chemotherapy across over 50 centers in the Netherlands and Belgium. "We're grateful to present our data at major medical meetings this spring, validating our science and the real-world utility of ultra-sensitive ctDNA-MRD technology," said David Kurtz, M.D., Ph.D., Chief Medical Officer of Foresight Diagnostics. "These presentations and the recent incorporation of ctDNA-MRD testing in B-cell lymphoma clinical guidelines give us confidence as we prepare to launch in the clinical market in 2026 and integrate Foresight CLARITY into routine clinical practice." Lead study authors Steven Wang, M.D., and Martine Chamuleau, M.D., Ph.D., Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL." Oral presentation details for EHA: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Aggressive Non-Hodgkin lymphoma - Clinical (Observational) Time: Thursday, June 12 | 5:00 p.m. – 5:15 p.m. CEST / 11:00 a.m. – 11:15 a.m. ET Room: Brown Hall 3 Abstract number: S240 Oral presentation details for ICML: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national HOVON trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Session 6: Liquid biopsy for response assessment Time: Thursday, June 19 | 2:15 p.m. – 2:30 p.m. CEST / 8:15 a.m. – 8:30 a.m. ET Room: Polivalente room, East Campus USI Article number: 041 In addition to the oral presentation, Foresight's technology will be highlighted in other presentations, including: Title: Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq After Axicabtagene ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-Cell Lymphoma (LBCL) Meeting: EHA 2025 Sponsor: Kite Pharma Presenter: Jeffrey Gregg, MD (Foresight Diagnostics) Session: Poster Session I | Poster Hall Date/Time: Friday, June 13 | 6:30 p.m. – 7:30 p.m. CEST / 12:30 p.m. – 1:30 p.m. ET Abstract: #PF1002 Title: The Correlation of Mutational Profiles and Valemetostat Efficacy in Patients With R/R PTCL in the Phase 2 VALENTINE-PTCL01 Trial Meeting: ICML 2025 Sponsor: Daiichi Sankyo Presenter: Pier Luigi Zinzani, MD, PhD (University of Bologna) Session: "Focus On" Session Biology and Therapy of T-cell Lymphomas | Room B Date/Time: Saturday, June 14 | 10:05 a.m. – 10:15 a.m. CEST / 4:05 a.m. – 4:15 a.m. ET Article Number: 164 About Foresight Diagnostics Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. SOURCE Foresight Diagnostics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期

2025-03-03

·moleculin.com

Moleculin Abstract Accepted for Poster Presentation at the Acute Leukemias XIX (ISALXIX) International Symposium

HOUSTON, March 3, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced its abstract has been accepted for poster presentation at the Acute Leukemias XIX (ISALXIX) International Symposium being held March 16-19, 2025 in Munich, Germany. Details for the poster presentation are as follows: Abstract: P002Session: Clinical Studies in AML and ALLTitle: Liposomal Annamycin in Combination with Cytarabine for Treatment of Acute Myeloid Leukemia (AML)Presenting Author: Cristina Papayannidis, MD, PhD, Adjunct professor, Department of Medical and Surgical Sciences, University of Bologna, Bologna Italy For more information about the ISALXIX International Symposium, visit the event website. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/moleculin-abstract-accepted-for-poster-presentation-at-the-acute-leukemias-xix-isalxix-international-symposium-302389270.html SOURCE Moleculin Biotech, Inc.

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