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Camilla Bøgelund Larsen Department of Endocrinology, Odense University Hospital, Denmark
Department of Clinical Research, University of Southern Denmark, Odense, Denmark

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Kristian Hillert Winther Department of Clinical Research, University of Southern Denmark, Odense, Denmark

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Per Karkov Cramon Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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Åse Krogh Rasmussen Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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Ulla Feldt-Rasmussen Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
Institute of Clinical Medicine, Faculty of Health and Clinical Sciences, Copenhagen University, Copenhagen, Denmark

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Nils Jakob Knudsen Department of Endocrinology, Bispebjerg University Hospital, Copenhagen, Denmark

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Jakob Bue Bjorner Department of Public Health, Copenhagen University, Copenhagen, Denmark
QualityMetric Inc, Johnston, Lincoln, Rhode Island, USA

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Lutz Schomburg Institute for Experimental Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

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Kamil Demircan Institute for Experimental Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

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Thilo Samson Chillon Institute for Experimental Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

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Jeppe Gram Medical Department, Endocrinology, University Hospital of South-West Jutland, Esbjerg, Denmark

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Stinus Gadegaard Hansen Medical Department, Endocrinology, University Hospital of South-West Jutland, Esbjerg, Denmark

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Frans Brandt Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Internal Medicine Research Unit, University Hospital of Southern Jutland, Aabenraa, Denmark

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Birte Nygaard Department of Endocrinology, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark

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Torquil Watt Department of Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
Institute of Clinical Medicine, Faculty of Health and Clinical Sciences, Copenhagen University, Copenhagen, Denmark

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Laszlo Hegedüs Department of Endocrinology, Odense University Hospital, Denmark
Department of Clinical Research, University of Southern Denmark, Odense, Denmark

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Steen Joop Bonnema Department of Endocrinology, Odense University Hospital, Denmark
Department of Clinical Research, University of Southern Denmark, Odense, Denmark

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Purpose

We investigated whether selenium supplementation improves quality-of-life (QoL) in patients with autoimmune thyroiditis (ID:NCT02013479).

Methods

We included 412 patients ≥18 years with serum thyroid peroxidase antibody (TPOAb) level ≥100 IU/mL in a multicentre double-blinded randomised clinical trial. The patients were allocated 1:1 to daily supplementation with either 200 μg selenium as selenium-enriched yeast or matching placebo tablets for 12 months, as add-on to levothyroxine (LT4) treatment. QoL, assessed by the Thyroid-related Patient-Reported-Outcome questionnaire (ThyPRO-39), was measured at baseline, after 6 weeks, and after 3, 6, 12, and 18 months.

Results

In total, 332 patients (81%) completed the intervention period, of whom 82% were women. Although QoL improved during the trial, no difference in any of the ThyPRO-39 scales was found between the selenium group and the placebo group after 12 months of intervention. In addition, employing linear mixed model regression no difference between the two groups was observed in the ThyPRO-39 composite score (28.8 (95% CI: 24.5–33.6) and 28.0 (24.5–33.1), respectively; P = 0.602). Stratifying the patients according to duration of the disease at inclusion, ThyPRO-39 composite score, TPOAb level, or selenium status at baseline did not significantly change the results. TPOAb levels after 12 months of intervention were lower in the selenium group than in the placebo group (1995 (95% CI: 1512–2512) vs 2344 kIU/L (1862–2951); P = 0.016) but did not influence LT4 dosage or free triiodothyronine–free thyroxine ratio.

Conclusion

In hypothyroid patients on LT4 therapy due to autoimmune thyroiditis, daily supplementation with 200 μg selenium or placebo for 12 months improved QoL to the same extent.

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