## Protocol Section
### Identification Module
**NCT ID:** NCT02013479

**Acronym:** CATALYST

**Brief Title:** Selenium Supplementation in Autoimmune Thyroiditis

**Official Title:** The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial

#### Organization Study ID Info
**ID:** DK-CATALYST
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2023-03-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-31

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-23

**Type:** ACTUAL

#### Start Date
**Date:** 2014-06

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2013-12-17
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-03
**Study First Submit QC Date:** 2013-12-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

**Class:** OTHER

**Name:** Bispebjerg Hospital

**Class:** OTHER

**Name:** Hospital of South West Jutland

**Class:** INDUSTRY

**Name:** Pharma Nord

**Class:** OTHER

**Name:** The Danish Medical Research Council

**Class:** OTHER

**Name:** Region of Southern Denmark

**Class:** OTHER

**Name:** University of Southern Denmark

#### Lead Sponsor

**Class:** OTHER

**Name:** Steen Bonnema

#### Responsible Party

**Investigator Affiliation:** Odense University Hospital

**Investigator Full Name:** Steen Bonnema

**Investigator Title:** Chief Physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- Autoimmune Thyroiditis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 415

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** SelenoPRECISE

**Intervention Names:**

- Dietary Supplement: SelenoPRECISE

**Label:** SelenoPRECISE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SelenoPRECISE

**Description:** Produced by Pharma Nord ApS, Vejle, Denmark

**Name:** SelenoPRECISE

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Produced by Pharma Nord ApS, Vejle, Denmark

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Measured in composite score based on the ThyPRO questionnaire

**Measure:** Thyroid related quality of life

**Time Frame:** 12 months after initation of intervention

#### Secondary Outcomes

**Measure:** Thyroid peroxidase antibody concentration (TPO-Ab)

**Time Frame:** 12 months after initation of intervention

**Measure:** Levothyroxine (LT4) dosage

**Time Frame:** 12 months after initation of intervention

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet

**Location 2:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Department of Endocrinology and Gastroenterology, Bispebjerg Hospital

**Location 3:**

**City:** Esbjerg

**Country:** Denmark

**Facility:** Department of Internal Medicine, Hospital of South West Denmark

**Location 4:**

**City:** Odense

**Country:** Denmark

**Facility:** Department of Endorcrinology and Metabolism, Odense University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Odense University Hospital

**Name:** Steen J Bonnema, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Odense University Hospital

**Name:** Laszlo Hegedüs, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Odense University Hospital

**Name:** Kristian H Winther, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Rigshospitalet, Denmark

**Name:** Torquil Watt, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Rigshospitalet, Denmark

**Name:** Per Cramon, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Rigshospitalet, Denmark

**Name:** Ulla Feldt-Rasmussen, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Rigshospitalet, Denmark

**Name:** Åse K Rasmussen, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** Hospital of South West Jutland

**Name:** Jeppe Gram, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** Bispebjerg Hospital, Denmark

**Name:** Nils J Knudsen, MD, DMSc

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 24716668

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16725

- Name: Thyroiditis

- Relevance: HIGH

- As Found: Thyroiditis

- ID: M26156

- Name: Hashimoto Disease

- Relevance: HIGH

- As Found: Autoimmune Thyroiditis

- ID: M16726

- Name: Thyroiditis, Autoimmune

- Relevance: HIGH

- As Found: Autoimmune Thyroiditis

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T3542

- Name: Lymphomatous Thyroiditis

- Relevance: HIGH

- As Found: Autoimmune Thyroiditis

### Condition Browse Module - Meshes

- ID: D000013966

- Term: Thyroiditis

- ID: D000013967

- Term: Thyroiditis, Autoimmune

- ID: D000050031

- Term: Hashimoto Disease

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15455

- Name: Selenium

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
