Department of Endocrinology and Metabolism, Odense University Hospital Kloevervaenget 4-6, DK-5000 Odense C, Odense, Denmark.
Trials. 2014 Apr 9;15:115. doi: 10.1186/1745-6215-15-115.
Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes in thyroid cells. Previous randomized controlled trials have found that selenium supplementation decreases thyroid-disease-specific antibody levels. We hypothesize that selenium might be beneficial in the treatment of chronic autoimmune thyroiditis.
METHODS/DESIGN: The CATALYST trial is an investigator-initiated randomized, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis.
age ≥18 years; serum thyroid peroxidase antibody level ≥100 IU/ml within the previous 12 months; treatment with levothyroxine and written informed consent.
previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, postpartum thyroiditis, Graves' orbitopathy; previous antithyroid drug treatment, radioiodine therapy or thyroid surgery; immune-modulatory or other medication affecting thyroid function; pregnancy, planned pregnancy or breastfeeding; allergy towards any intervention or placebo component; intake of selenium supplementation >55 μg/day; inability to read or understand Danish or lack of informed consent. The trial will include 2 × 236 participants. The experimental intervention and control groups will receive 200 μg selenium-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise®. The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire. Secondary outcomes include serum thyroid peroxidase antibody concentration; serum triiodothyronine/thyroxine ratio; levothyroxine dosage; adverse reactions and serious adverse reactions and events.
In this pragmatic trial, participating patients follow their usual treatment at their usual hospitals. In order to collect high-quality data on the clinical course and quality of life, and to minimize missing data, an elaborate trial management system has been designed. 12 months intervention duration was selected in consideration of the primary outcome, thyroid-related quality of life.
ClinicalTrials.gov ID: NCT02013479.
慢性自身免疫性甲状腺炎患者的健康相关生活质量受损。甲状腺含有高浓度的硒，特定的硒蛋白酶家族对免疫功能至关重要，并催化甲状腺细胞中的甲状腺激素代谢和氧化还原过程。先前的随机对照试验发现，硒补充剂可降低甲状腺疾病特异性抗体水平。我们假设硒可能对治疗慢性自身免疫性甲状腺炎有益。
方法/设计：CATALYST 试验是一项由研究者发起的、随机、双盲、多中心临床试验，比较硒补充剂与安慰剂治疗慢性自身免疫性甲状腺炎患者的疗效。
年龄≥18 岁；过去 12 个月内血清甲状腺过氧化物酶抗体水平≥100IU/ml；接受左甲状腺素治疗并签署书面知情同意书。
既往诊断为毒性结节性甲状腺肿、格雷夫斯甲亢、产后甲状腺炎、格雷夫斯眼病；既往抗甲状腺药物治疗、放射性碘治疗或甲状腺手术；影响甲状腺功能的免疫调节剂或其他药物；妊娠、计划妊娠或哺乳期；对任何干预措施或安慰剂成分过敏；每天摄入硒补充剂>55μg；无法阅读或理解丹麦语或缺乏知情同意。该试验将纳入 2×236 名参与者。实验组和对照组将每天服用 200μg 富硒酵母或匹配的安慰剂片，为期 12 个月。实验组补充剂为 SelenoPrecise®。主要结局是使用甲状腺患者报告结局（ThyPRO）问卷评估甲状腺相关生活质量。次要结局包括血清甲状腺过氧化物酶抗体浓度；血清三碘甲状腺原氨酸/甲状腺素比值；左甲状腺素剂量；不良反应和严重不良反应事件。
在这项实用试验中，参与患者在其常规医院接受常规治疗。为了收集关于临床病程和生活质量的高质量数据，并最大限度地减少数据缺失，设计了一个精心的试验管理系统。考虑到主要结局，即甲状腺相关生活质量，选择了 12 个月的干预时间。
ClinicalTrials.gov 注册号：NCT02013479。
