Clinical Trial: Selenium Supplementation in Autoimmune Thyroiditis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial

Brief 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.

Detailed Summary:

Background: Chronic autoimmune thyroiditis (AIT) is a common autoimmune disease that often leads to impaired function of the thyroid gland, increases in incidence with age, and has an 8-9 time female preponderance. Quality of life is often impaired and complaints persist in a considerable number of patients, even after restoration of euthyroidism. The autoimmune component of the disease has been suggested as an explanation for this. Selenium is a micro nutritive essential for human health and the thyroid gland has the highest selenium concentration of all human tissues. Selenoproteins catalyse thyroid hormone metabolism and anti-oxidative processes in thyrocytes. In addition they are important to immune function. In Denmark, patients with AIT have lower blood selenium concentration than the background population. The majority of 13 randomised trials have shown that selenium supplementation decreases serum thyroid peroxidase antibody levels (TPO-Ab) in patients with AIT, when compared with placebo. We hypothesise that adjuvant selenium may be beneficial in the treatment of AIT.

Objectives: To investigate if selenium supplementation versus placebo adjuvant to the standard treatment with levothyroxine (LT4) in patients with AIT will lead to improved thyroid specific quality of life, and reduced autoimmune activity.

Design and trial size: The CATALYST trial is an investigator-initiated randomised, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with AIT. The trial will include 472 participants (2 X 236) from four clinical trial sites.

Intervention and duration: The experimental intervention group will receive 200 μg selenium-enriched yeast as two oral tablets once daily for 12 months. The control group will receive two placebo tab
Sponsor: Steen Bonnema

Current Primary Outcome: Thyroid related quality of life [ Time Frame: 12 months after initation of intervention ]

Measured in composite score based on the ThyPRO questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Thyroid peroxidase antibody concentration (TPO-Ab) [ Time Frame: 12 months after initation of intervention ]
  • Levothyroxine (LT4) dosage [ Time Frame: 12 months after initation of intervention ]


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: December 3, 2013
Date Started: June 2014
Date Completion: September 2020
Last Updated: June 6, 2016
Last Verified: June 2016