Fletcher Jane, Bedson Emma, Brown Michaela, Hewison Martin, Swift Amelia, Cooper Sheldon C
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Trust, Edgbaston, Birmingham, B15 2TH, England.
Liverpool Clinical Trials Centre, University of Liverpool, 2nd Floor Institute in the Park, Alder Hey Children's Hospital, Eaton Road, Liverpool, L12 2AP, England.
Pilot Feasibility Stud. 2021 Mar 20;7(1):79. doi: 10.1186/s40814-021-00813-3.
Crohn's disease (CD) is a principal form of inflammatory bowel disease, affecting approximately 1 in every 650 people in the UK. Vitamin D deficiency is common in approximately 57.7% of CD patients; with anaemia occurring in about 43% of patients. There is growing evidence that supplementing CD patients who are vitamin D deficient may be effective in reducing the severity of CD symptoms and reducing iron-deficiency anaemia. Nevertheless, National Institute for Health and Care Excellence guidance regarding the management of CD does not address vitamin D deficiency in these patients. The aims of the study are (1) to determine the prevalence of vitamin D deficiency in adults with CD in Birmingham, UK and (2) to assess the feasibility of conducting a multi-site randomised controlled trial in adult patients with CD and vitamin D deficiency.
D-CODE consists of two parts-a screening study and an open-label randomised controlled feasibility study. 1. Vitamin D screening Three hundred patients, 18 years or older with CD will have a dried blood spot test to measure vitamin D levels. Dietary and sun exposure data will be collected. Eligible patients with low levels of vitamin D will be invited to participate in the feasibility study. 2. Feasibility study Fifty participants with CD and vitamin D deficiency will be randomised to receive either a low (400 IU daily for 24 weeks) or high (3200 IU daily for 12 weeks then vitamin D3 800 IU daily for 12 weeks) dose of vitamin D3 oral supplementation. Patient-reported outcomes (Inflammatory Bowel Disease Questionnaire, EQ-5D-5L and Crohn's Disease Activity Index Score) will be collected at weeks 0 and 24. Biochemical monitoring will take place at weeks 0, 12 and 24 and will measure 25-hydroxyvitamin D, corrected calcium, albumin, parathyroid hormone, hepcidin, other vitamin D metabolites, iron studies and C-reactive protein. Faecal calprotectin will be measured at weeks 0 and 24.
A key aspect of D-CODE is the identification of vitamin D deficiency prior to supplementation. It is hoped that this feasibility study will lead to a definitive trial that will investigate the benefits of treating vitamin D deficiency in patients with CD.
The trial has been registered with EudraCT number 2018-003910-42, ClinicalTrials.gov identifier NCT03718182 and ISRCTN number 15717783.
克罗恩病（CD）是炎症性肠病的一种主要形式，在英国，每650人中约有1人受其影响。约57.7%的CD患者存在维生素D缺乏；约43%的患者患有贫血。越来越多的证据表明，对维生素D缺乏的CD患者进行补充治疗可能有效减轻CD症状的严重程度并减少缺铁性贫血。然而，英国国家卫生与临床优化研究所关于CD管理的指南并未涉及这些患者的维生素D缺乏问题。本研究的目的是：（1）确定英国伯明翰市成年CD患者中维生素D缺乏的患病率；（2）评估在成年CD和维生素D缺乏患者中开展多中心随机对照试验的可行性。
D-CODE研究由两部分组成——一项筛查研究和一项开放标签随机对照可行性研究。1. 维生素D筛查 300名18岁及以上的CD患者将接受干血斑检测以测量维生素D水平。同时收集饮食和阳光暴露数据。符合条件的维生素D水平低的患者将被邀请参加可行性研究。2. 可行性研究 50名患有CD和维生素D缺乏的参与者将被随机分组，分别接受低剂量（每日400 IU，共24周）或高剂量（前12周每日3200 IU，后12周每日800 IU维生素D3）的维生素D3口服补充剂。将在第0周和第24周收集患者报告的结局（炎症性肠病问卷、EQ-5D-5L和克罗恩病活动指数评分）。在第0周、第12周和第24周进行生化监测，测量25-羟维生素D、校正钙、白蛋白、甲状旁腺激素、铁调素、其他维生素D代谢物、铁指标和C反应蛋白。在第0周和第24周测量粪便钙卫蛋白。
D-CODE的一个关键方面是在补充之前识别维生素D缺乏。希望这项可行性研究将促成一项确定性试验，以研究治疗CD患者维生素D缺乏的益处。
该试验已在欧洲药品管理局临床试验数据库注册，注册号为2018-003910-42，在美国国立医学图书馆临床试验注册库的标识符为NCT03718182，在国际标准随机对照试验编号注册库的编号为15717783。
