Loveikyte Roberta, Duijvestein Marjolijn, Mujagic Zlatan, Goetgebuer Rogier L, Dijkstra Gerard, van der Meulen-de Jong Andrea E
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands
Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2024 Jan 30;14(1):e077511. doi: 10.1136/bmjopen-2023-077511.
Iron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin-a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption-has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment.
PRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis.
The study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request.
Prospectively registered in the https://clinicaltrials.gov/ and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID: NCT05456932) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).
缺铁性贫血（IDA）是炎症性肠病（IBD）最常见的全身表现，对生活质量（QoL）和疾病转归有不利影响。缺铁（ID），无论有无贫血，由于ID（A）的多因素性质及其频繁复发，给IBD患者带来了诊断和治疗挑战。铁调素升高——一种调节全身铁可用性和肠道铁吸收的全身铁调节因子——与IBD患者口服铁吸收不良有关。因此，铁调素有助于治疗决策。在本研究中，我们调查铁调素是否能预测正在接受抗炎治疗的活动性IBD患者对口服和静脉补铁的反应。
PRIme是一项探索性、多中心、开放标签的随机试验。所有患有活动性IBD和ID（A）的成年患者将接受资格评估。参与者（n = 90）将在荷兰的五家学术医院招募，并随机分为三组（1:1:1）：口服富马酸亚铁、口服麦芽酚铁或静脉补铁。将在基线以及6周、14周和24周后收集临床和生化数据。将采集血样以测量铁调素和其他与铁状态相关的生物标志物。此外，将评估患者报告的关于QoL和疾病负担的结果。主要结局是铁调素作为铁治疗反应预测生物标志物的效用，将使用受试者工作特征曲线分析进行评估。
该研究已获得莱顿大学医学中心机构审查委员会（IRB编号：P21.109）和其他研究地点的批准。所有参与者将提供书面知情同意书以参加该研究。研究结果将发表在同行评审期刊上，并在科学会议上传播；数据集将根据合理要求提供。
