Abstract
BackgroundPatients 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/DesignThe CATALYST trial is an investigator-initiated randomized, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis. Inclusion criteria: age ≥18 years; serum thyroid peroxidase antibody level ≥100 IU/ml within the previous 12 months; treatment with levothyroxine and written informed consent. Exclusion criteria: 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.DiscussionIn 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.Trial registrationClinicalTrials.gov ID: NCT02013479.
Highlights
Patients with chronic autoimmune thyroiditis have impaired health-related quality of life
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
Summary
The data available from previous trials warrant further investigation, since a benefit from selenium supplementation is still unproven in patients with AIT. Intervention durations of 3, 6, 9, and 12 months using different selenium formulations have shown positive effects on serum TPO-Ab concentrations This trial will be the largest yet, with 472 participants, and the first to measure changes in quality of life, by ThyPRO, as the primary outcome. The 6-month postintervention follow-up period was added to assess sustained effects This trial will look into selenium’s mechanisms of action in AIT, by measuring biomarkers of immunological activity, and will be the first to evaluate whether selenium supplementation affects LT4 dosage. It is of major importance to the CATALYST trial’s initiators that the results will be as directly applicable to daily clinical practice as possible It will be conducted as a pragmatic trial [52], with participating patients following their usual treatment at their usual. TW: conception and design of the trial, data collection and analysis, critical revision and approval of final manuscript.
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