OPEN Research Support
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Associate Professor and Chief Physician
Steen Joop Bonnema
Department of Endocrionology, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.03.2014  
Slut 01.01.2020  
 



The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST)

Short summary

In this randomized controlled trial, the aim is to rule selenium supplementation in or out of treatment of chronic autoimmune thyroiditis. CATALYST is set up as a pragmatic trial, with participating patients following their usual treatment, i.e. treatment of hypothyroidism with thyroid hormone substitution, at their usual hospitals. In order to still collect high quality data on the clinical disease course, and to minimize missing data, an elaborate trial management system has been designed.


Rationale

Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyse thyroid hormone metabolism, and redox processes in thyroid cells. Previous randomised clinical trials have found that selenium supplementation decreases thyroid disease specific antibody levels. We hypothesise that selenium may be beneficial in the treatment of chronic autoimmune thyroiditis.


Description of the cohort

The CATALYST trial is an investigator-initiated randomised, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with chronic autoimmune thyroiditis. Inclusion criteria: age over or equal to 18 years; serum thyroid peroxidase antibody level over or equal to 100 IU/mL within the past 12 months; treatment with levothyroxine for hypothyroidism; written informed consent. Exclusion criteria: Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis, Graves' orbitopathy; previous anti-thyroid drug treatment, radioiodine therapy or thyroid surgery; immune-modulatory or other medication affecting thyroid function; pregnancy, planned pregnancy or breast-feeding; allergy towards any intervention or placebo component; intake of selenium supplementation > 55 ug/d; inability to read or understand Danish; or lack of informed consent. The trial will include 2 X 236 participants. The experimental intervention and control groups will receive 200 ug selenium-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise®. The primary outcome is thyroid-related quality of life assessed by the ThyPRO questionnaire. Secondary outcomes include serum thyroid peroxidase antibody concentration; serum triiodothyronine/thyroxine ratio; levothyroxine dosage; immunological and oxidative stress biomarkers; adverse reactions and serious adverse effects and events.


Data and biological material

The quality of life questionaire is collected and analysed via patient-reported outcomes, administered through the TDMS at baseline and follow-up after 6 weeks and 3, 6, 12, 18 months. Weight, medical treatment, LT4 dosage and consumption of additional selenium are analysed via data obtained in eCRFs at trial visits and administered through the trial data management system (TDMS) at baseline and follow-up after 3, 12 and 18 months. Analyzed the same way are Thyroid echogenicity (at baseline and follow-up after 12 months), Table count (Follow-up after 6 and 12 months) and adverse reactions (Follow-up after 6, 12 and 18 months). TSH, FT4, FT3, TPO-Ab, Immunological and oxidative stress biomarkers, Selenium and Creatinine/iodine ratio in spot urine are analysed in blood or urine samples obtained at trial visits at baseline and after 3, 12 and 18 months (Creatinine/iodine ratio in spot urine only at baseline). Serious adverse reactions and events (SARs, SUSARs and SAEs) are analysed via public national registries at the end of the trial.


Collaborating researchers and departments

Department of Endocrinology, Odense University Hospital

  • Associate Professor and Sponsor Steen Bonnema, MD, DMSc, PhD
  • PhD-student and Coordinating investigator Kristian Hillert Winther, MD
  • Professor and Principal investigator Laszlo Hegedüs, MD, DMSc

Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet

  • Senier Researcher and Principal investigator Torquil Watt, MD, PhD
  • Professor and Investigator Ulla Feldt-Rasmussen, MD, DMSc
  • Chief Physician and Investigator Åse Krogh Rasmussen, MD, DMSc
  • PhD-student and Investigator Per Cramon, MD

Department of Endocrinology, Bispebjerg Hospital

  • Associate Professor and Principal Investigator Nils Knudsen, MD, DMSc, PhD

Medical Department, Hospital of Southwest Denmark

  • Associate Professor and Principal Investigator Jeppe Gram, MD, PhD

Department of Internal Medicine, Copenhagen University Hospital Gentofte

  • Professor and Principal Investigator Tina Visbøll, MD, DMSc

Copenhagen Trial Unit, Centre for Clinical Intervention Research

  • Head of Department and Investigator Christian Glud, MD, DMSc

National Research Centre for the Working Environment

  • Professor and Investigator Jakob Bjørner, MD, PhD

Department of Palliative Medicine, Bispebjerg Hospital

  • Professor and Investigator Mogens Grønvold, MD, DMSc, PhD

Publications associated with the project

The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial. / Winther KH, Watt T, Bjorner JB, Cramon P, Feldt-Rasmussen U, Gluud C, Gram J, Groenvold M, Hegedus L, Knudsen N, Rasmussen AK, Bonnema SJ. Trials 2014; 15:115.

Development and implementation of PROgmatic: A clinical trial management system for pragmatic multi-centre trials, optimised for electronic data capture and patient-reported outcomes. / Cramon P, Rasmussen AK, Bonnema SJ, Bjorner JB, Feldt-Rasmussen U, Groenvold M, Hegedus L, Watt T. 2014 Clin Trials 11:344-354