Selenium Supplementation in Autoimmune Thyroiditis
CATALYST
The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial
1 other identifier
interventional
415
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2023
CompletedOctober 31, 2023
October 1, 2023
8.8 years
December 3, 2013
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Thyroid related quality of life
Measured in composite score based on the ThyPRO questionnaire
12 months after initation of intervention
Secondary Outcomes (2)
Thyroid peroxidase antibody concentration (TPO-Ab)
12 months after initation of intervention
Levothyroxine (LT4) dosage
12 months after initation of intervention
Study Arms (2)
SelenoPRECISE
EXPERIMENTALSelenoPRECISE
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steen Bonnemalead
- Rigshospitalet, Denmarkcollaborator
- Bispebjerg Hospitalcollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
- Pharma Nordcollaborator
- The Danish Medical Research Councilcollaborator
- Region of Southern Denmarkcollaborator
- University of Southern Denmarkcollaborator
Study Sites (4)
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
Related Publications (2)
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 Jan 1;13(1):e230175. doi: 10.1530/ETJ-23-0175. Online ahead of print.
PMID: 38215286DERIVEDWinther 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: 24716668DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Esbjerg Hospital - University Hospital of Southern Denmark
- PRINCIPAL INVESTIGATOR
Nils J Knudsen, MD, DMSc
Bispebjerg Hospital, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 17, 2013
Study Start
June 1, 2014
Primary Completion
March 23, 2023
Study Completion
March 23, 2023
Last Updated
October 31, 2023
Record last verified: 2023-10