The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized...

Area of Science:

• Endocrinology
• Immunology
• Nutritional Science

Background:

• Chronic autoimmune thyroiditis negatively impacts patients' health-related quality of life.
• The thyroid gland has high selenium concentrations, with selenoproteins vital for immune function and thyroid hormone metabolism.
• Previous studies suggest selenium supplementation can lower thyroid-specific antibody levels.

Purpose of the Study:

• To evaluate the efficacy of selenium supplementation in improving quality of life for patients with chronic autoimmune thyroiditis.
• To assess the impact of selenium on thyroid antibody levels and thyroid hormone metabolism.

Main Methods:

• The CATALYST trial is a randomized, blinded, multicenter study comparing selenium-enriched yeast (200 μg/day) with placebo for 12 months.
• Inclusion criteria: age ≥18, serum thyroid peroxidase antibody level ≥100 IU/ml, levothyroxine treatment.
• Primary outcome: thyroid-related quality of life (ThyPRO questionnaire); secondary outcomes: antibody levels, T3/T4 ratio, levothyroxine dosage.

Main Results:

• Selenium supplementation's effect on quality of life and antibody levels is under investigation.
• The trial aims to provide robust data on selenium's role in managing chronic autoimmune thyroiditis.

Conclusions:

• The CATALYST trial is a pragmatic study designed to collect high-quality data on clinical course and quality of life.
• A 12-month intervention period was chosen to adequately assess the primary outcome of thyroid-related quality of life.