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CompletedNCT02013479CATALYSTUpdated Oct 31, 2023

Selenium Supplementation in Autoimmune Thyroiditis

An interventional study of SelenoPRECISE and Placebo in Autoimmune Thyroiditis, sponsored by Steen Bonnema. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Steen Bonnema · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
415
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autoimmune Thyroiditis
03

In context

Thyroiditis, Autoimmune

27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.

This study's enrollment of 415 is above the median of 70 across 19 interventional studies indexed under Thyroiditis, Autoimmune.

Browse Thyroiditis, Autoimmune studies →

Lead sponsor

Steen Bonnema is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
415 participants (actual)

Study arms

  • Experimental
    SelenoPRECISE

    SelenoPRECISE

    Dietary Supplement: SelenoPRECISE

  • Placebo comparator
    Placebo

    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementSelenoPRECISE

    Produced by Pharma Nord ApS, Vejle, Denmark

  • Dietary supplementPlacebo

    Produced by Pharma Nord ApS, Vejle, Denmark

06

What researchers measure

Primary outcomes

  1. Thyroid related quality of life

    Measured in composite score based on the ThyPRO questionnaire

    Time frame: 12 months after initation of intervention

Secondary outcomes

  1. Thyroid peroxidase antibody concentration (TPO-Ab)

    Time frame: 12 months after initation of intervention

  2. Levothyroxine (LT4) dosage

    Time frame: 12 months after initation of intervention

07

Study locations

4 sites
  • Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
    Copenhagen, Denmark
  • Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
    Copenhagen, Denmark
  • Department of Internal Medicine, Hospital of South West Denmark
    Esbjerg, Denmark
  • Department of Endorcrinology and Metabolism, Odense University Hospital
    Odense, Denmark
08

References and documents

Publications

  • 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. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial. Trials. 2014 Apr 9;15:115. doi: 10.1186/1745-6215-15-115. PubMed 24716668 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Mar 2023 and a completion of Mar 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2013
First posted
Dec 17, 2013
Start
Jun 2014
Primary completionActual
Mar 23, 2023
CompletionActual
Mar 23, 2023
Last update
Oct 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02013479
Lead sponsor
Steen Bonnema
Collaborators
Rigshospitalet, Denmark, Bispebjerg Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Pharma Nord, The Danish Medical Research Council, Region of Southern Denmark, University of Southern Denmark
Responsible party
Steen Bonnema (Chief Physician, Odense University Hospital) — Sponsor-investigator
First posted
Dec 17, 2013
Start date
Jun 2014
Primary completion
Mar 23, 2023
Completion
Mar 23, 2023
Last update
Oct 31, 2023

Study contacts

Steen J Bonnema, MD, DMSc
principal investigator · Odense University Hospital
Laszlo Hegedüs, MD, DMSc
principal investigator · Odense University Hospital
Kristian H Winther, MD
principal investigator · Odense University Hospital
Torquil Watt, MD, PhD
principal investigator · Rigshospitalet, Denmark
Per Cramon, MD
principal investigator · Rigshospitalet, Denmark
Ulla Feldt-Rasmussen, MD, DMSc
principal investigator · Rigshospitalet, Denmark
Åse K Rasmussen, MD, DMSc
principal investigator · Rigshospitalet, Denmark
Jeppe Gram, MD, PhD
principal investigator · Esbjerg Hospital - University Hospital of Southern Denmark
Nils J Knudsen, MD, DMSc
principal investigator · Bispebjerg Hospital, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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