CompletedNot Applicable

Selenium Supplementation in Autoimmune Thyroiditis

Denmark415 participantsStarted 2014-06

Plain-language summary

Our aim is to investigate if selenium supplementation versus placebo adjuvant to the standard treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will lead to improved thyroid specific quality of life, and reduced autoimmune activity. The trial will include 472 participants (2 X 236) from four clinical trial sites.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years.
✓. Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months.
✓. Receiving LT4 treatment.
✓. Written informed consent.

Exclusion criteria

✕. Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO).
✕. Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery.
✕. Previous diagnosis of non-melanoma skin cancer.
✕. Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial.
✕. Systemic immunomodulatory medication.
✕. Other medication known to affect thyroid function.
✕. Pregnancy, breastfeeding, or planned pregnancy within 18 months.
✕. Allergy towards the components in the selenium or placebo pills.

What they're measuring

Thyroid related quality of life

Timeframe: 12 months after initation of intervention

Trial details

NCT IDNCT02013479

SponsorSteen Bonnema

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-23

View on ClinicalTrials.gov More Autoimmune Thyroiditis trials