Selenium Supplementation in Autoimmune Thyroiditis (CATALYST)
|Autoimmune Thyroiditis||Dietary Supplement: SelenoPRECISE Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial|
- Thyroid related quality of life [ Time Frame: 12 months after initation of intervention ]Measured in composite score based on the ThyPRO questionnaire
- 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 ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
Dietary Supplement: SelenoPRECISE
Produced by Pharma Nord ApS, Vejle, Denmark
Placebo Comparator: Placebo
Dietary Supplement: Placebo
Produced by Pharma Nord ApS, Vejle, Denmark
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013479
|Contact: Steen J Bonnema, MD, DMScemail@example.com|
|Contact: Kristian H Winther, MDfirstname.lastname@example.org|
|Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet||Recruiting|
|Department of Endocrinology and Gastroenterology, Bispebjerg Hospital||Not yet recruiting|
|Department of Internal Medicine, Hospital of South West Denmark||Not yet recruiting|
|Department of Endorcrinology and Metabolism, Odense University Hospital||Recruiting|
|Principal Investigator:||Steen J Bonnema, MD, DMSc||Odense University Hospital|
|Principal Investigator:||Laszlo Hegedüs, MD, DMSc||Odense University Hospital|
|Principal Investigator:||Kristian H Winther, MD||Odense University Hospital|
|Principal Investigator:||Torquil Watt, MD, PhD||Rigshospitalet, Denmark|
|Principal Investigator:||Per Cramon, MD||Rigshospitalet, Denmark|
|Principal Investigator:||Ulla Feldt-Rasmussen, MD, DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Åse K Rasmussen, MD, DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Jeppe Gram, MD, PhD||Hospital of South West Denmark|
|Principal Investigator:||Nils J Knudsen, MD, DMSc||Bispebjerg Hospital, Denmark|