Selenium Supplementation in Autoimmune Thyroiditis (CATALYST)

• ClinicalTrials.gov Identifier: NCT02013479
• Recruitment Status: Active, not recruiting
• First Posted: December 17, 2013
• Last Update Posted: September 9, 2021
• Sponsor: Steen Bonnema
• Collaborators: Rigshospitalet, Denmark; Bispebjerg Hospital; Hospital of South West Denmark; Pharma Nord; The Danish Medical Research Council; Region of Southern Denmark; University of Southern Denmark
• Information provided by (Responsible Party): Steen Bonnema, Odense University Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Autoimmune Thyroiditis	Dietary Supplement: SelenoPRECISE; Dietary Supplement: Placebo	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 415 participants
• 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
• Study Start Date: June 2014
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: SelenoPRECISE; SelenoPRECISE	Dietary Supplement: SelenoPRECISE; Produced by Pharma Nord ApS, Vejle, Denmark
Placebo Comparator: Placebo; Placebo	Dietary Supplement: Placebo; Produced by Pharma Nord ApS, Vejle, Denmark

Outcome Measures

Primary Outcome Measures :

1. Thyroid related quality of life [ Time Frame: 12 months after initation of intervention ]
   Measured in composite score based on the ThyPRO questionnaire

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Denmark

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

Sponsors and Collaborators

Steen Bonnema

Rigshospitalet, Denmark

Bispebjerg Hospital

Hospital of South West Denmark

Pharma Nord

The Danish Medical Research Council

Region of Southern Denmark

University of Southern Denmark

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: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Winther KH, Watt T, Bjørner JB, Cramon P, Feldt-Rasmussen U, Gluud C, Gram J, Groenvold M, Hegedüs L, Knudsen N, Rasmussen ÅK, 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.

• Responsible Party: Steen Bonnema, Chief Physician, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02013479
• Other Study ID Numbers: DK-CATALYST
• First Posted: December 17, 2013
• Last Update Posted: September 9, 2021
• Last Verified: September 2021

Additional relevant MeSH terms:

Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases