Autoimmune ThyroiditisCATALYSTNCT02013479
Selenium Supplementation in Autoimmune Thyroiditis
A study testing SelenoPRECISE in people with Autoimmune Thyroiditis, run by Steen Bonnema at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Thyroiditis
- What is being tested?
- SelenoPRECISE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 4 sitesDenmark
- Study dates
- Jun 2014to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months.
- Receiving LT4 treatment.
- Serum-TSH ≥ 4.0 mU/L measured prior to treatment initiation
- Written informed consent.
Who cannot join
- Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO).
- Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery.
- Previous diagnosis of non-melanoma skin cancer.
- Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial.
- Systemic immunomodulatory medication.
- Other medication known to affect thyroid function.
Show all 11Show fewer
- Pregnancy, breastfeeding, or planned pregnancy within 18 months.
- Allergy towards the components in the selenium or placebo pills.
- Intake of selenium supplementation ≥ 55 μg/d.
- Unable to read or understand Danish.
- Lack of informed consent
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen
Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
Copenhagen
Department of Internal Medicine, Hospital of South West Denmark
Esbjerg
Department of Endorcrinology and Metabolism, Odense University Hospital
Odense
About this study
Official title: 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.
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.
- Conditions
- Autoimmune Thyroiditis
- Being tested
- SelenoPRECISE, Placebo
- Medical subject headings
- Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelenoPRECISEDietary supplement
Produced by Pharma Nord ApS, Vejle, Denmark
PlaceboDietary supplement
Produced by Pharma Nord ApS, Vejle, Denmark
| Study group | Role | What they receive |
|---|---|---|
| SelenoPRECISE | Experimental | SelenoPRECISE Receives: Dietary Supplement: SelenoPRECISE |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid related quality of life
Measured in composite score based on the ThyPRO questionnaire
Measured: 12 months after initation of intervention
Secondary outcomes (2)
Thyroid peroxidase antibody concentration (TPO-Ab)
Measured: 12 months after initation of intervention
Levothyroxine (LT4) dosage
Measured: 12 months after initation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startJun 2014
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen Bonnema
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, 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
- Sponsor-investigator, Steen Bonnema, Odense University Hospital
- Investigators
- Steen J Bonnema, MD, DMSc, Principal investigator, Odense University HospitalLaszlo Hegedüs, MD, DMSc, Principal investigator, Odense University HospitalKristian H Winther, MD, Principal investigator, Odense University HospitalTorquil Watt, MD, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletPer Cramon, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletUlla Feldt-Rasmussen, MD, DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletÅse K Rasmussen, MD, DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletJeppe Gram, MD, PhD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013479
- Sponsor's protocol ID
- DK-CATALYST
- Acronym
- CATALYST
- Status last verified
- Oct 2023
- First submitted
- 3 Dec 2013
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen C, Winther KH, Cramon PK, Rasmussen AK, Feldt-Rasmusssen U, Knudsen NJ, Bjorner JB, Schomburg L, Demircan K, Chillon TS, Gram J, Hansen SG, Brandt F, Nygaard B, Watt T, Hegedus L, Bonnema SJ. Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism. Eur Thyroid J. 2024 Feb 5;13(1):e230175. doi: 10.1530/ETJ-23-0175.
PubMed 38215286Winther 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial
- ClinicalTrials.gov ID
- NCT02013479
- Acronym / sponsor ID
- CATALYST / DK-CATALYST
- Conditions
- Autoimmune Thyroiditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Steen BonnemaUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Pharma Nord, The Danish Medical Research Council, Region of Southern Denmark, University of Southern Denmark
- Study start
- Jun 2014
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SelenoPRECISE | Experimental | Dietary Supplement: SelenoPRECISESelenoPRECISE |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months.
- Receiving LT4 treatment.
- Written informed consent.
Key exclusion criteria (11 listed)
- Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO).
- Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery.
- Previous diagnosis of non-melanoma skin cancer.
- Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial.
- Systemic immunomodulatory medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelenoPRECISEProduced by Pharma Nord ApS, Vejle, Denmark | Dietary supplement | SelenoPRECISE |
| PlaceboProduced by Pharma Nord ApS, Vejle, Denmark | Dietary supplement | Placebo |
Primary outcome
Thyroid related quality of life
Time frame: 12 months after initation of intervention
Measured in composite score based on the ThyPRO questionnaire
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 38215286Larsen C, Winther KH, Cramon PK, Rasmussen AK, Feldt-Rasmusssen U, Knudsen NJ, Bjorner JB, Schomburg L, Demircan K, Chillon TS, Gram J, Hansen SG, Brandt F, Nygaard B, Watt T, Hegedus L, Bonnema SJ. Selenium supplementation and placebo are equally effective in improving quality of life in patients with hypothyroidism. Eur Thyroid J. 2024 Feb 5;13(1):e230175. doi: 10.1530/ETJ-23-0175.
- Derived from this study: PubMed 24716668Winther 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelenoPRECISE in people with Autoimmune Thyroiditis, run by Steen Bonnema at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid related quality of life (time frame: 12 months after initation of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.