Selenium Supplementation in Autoimmune Thyroiditis

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 tablets, identical in appearance, taste and smell, once daily for 12 months. Six months additional follow-up leads to a trial duration of 18 months. The experimental supplement will be SelenoPrecise® by Pharma Nord ApS. Time schedule: July 2012 - February 2014: preparation, approval and trial registration . March 2014: first participant first visit. March 2016: last participant first visit. September 2017: last participant last visit. Autumn 2017: analysis of biological samples and data, preparation of manuscripts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02013479
Study type	Interventional
Source	Odense University Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 2014
Completion date	March 23, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Selenium Supplementation in Autoimmune Thyroiditis — CATALYST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms