Selenium Supplementation in Autoimmune Thyroiditis (CATALYST)

October 30, 2023 updated by: Steen Bonnema

The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial

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.

Study Overview

Detailed 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 Type

Interventional

Enrollment (Actual)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
      • Copenhagen, Denmark
        • Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
      • Esbjerg, Denmark
        • Department of Internal Medicine, Hospital of South West Denmark
      • Odense, Denmark
        • Department of Endorcrinology and Metabolism, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months.
  3. Receiving LT4 treatment.

    - Serum-TSH ≥ 4.0 mU/L measured prior to treatment initiation

  4. Written informed consent.

Exclusion Criteria:

  1. Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO).
  2. Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery.
  3. Previous diagnosis of non-melanoma skin cancer.
  4. Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial.
  5. Systemic immunomodulatory medication.
  6. Other medication known to affect thyroid function.
  7. Pregnancy, breastfeeding, or planned pregnancy within 18 months.
  8. Allergy towards the components in the selenium or placebo pills.
  9. Intake of selenium supplementation ≥ 55 μg/d.
  10. Unable to read or understand Danish.
  11. Lack of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Produced by Pharma Nord ApS, Vejle, Denmark
Experimental: SelenoPRECISE
Produced by Pharma Nord ApS, Vejle, Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid related quality of life
Time Frame: 12 months after initation of intervention
Measured in composite score based on the ThyPRO questionnaire
12 months after initation of intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • 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: Åse K Rasmussen, MD, DMSc, Rigshospitalet, Denmark
  • Principal Investigator: Jeppe Gram, MD, PhD, Hospital of South West Jutland
  • Principal Investigator: Nils J Knudsen, MD, DMSc, Bispebjerg Hospital, Denmark
  • Principal Investigator: Ulla Feldt-Rasmussen, MD, DMSc, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimated)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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