Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02013479 |
| Other study ID # |
DK-CATALYST |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2014 |
| Est. completion date |
March 23, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
