Selenium Supplementation in Autoimmune Thyroiditis (CATALYST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Odense University Hospital
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Bispebjerg Hospital
Hospital of South West Denmark
Pharma Nord
The Danish Medical Research Council
Region Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Steen Bonnema, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02013479
First received: December 3, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 Intervention
Autoimmune Thyroiditis
Dietary Supplement: SelenoPRECISE
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Thyroid related quality of life [ Time Frame: 12 months after initation of intervention ] [ Designated as safety issue: No ]
    Measured in composite score based on the ThyPRO questionnaire


Secondary Outcome Measures:
  • Thyroid peroxidase antibody concentration (TPO-Ab) [ Time Frame: 12 months after initation of intervention ] [ Designated as safety issue: No ]
  • Levothyroxine (LT4) dosage [ Time Frame: 12 months after initation of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 472
Study Start Date: June 2014
Estimated Study Completion Date: September 2027
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013479

Contacts
Contact: Steen J Bonnema, MD, DMSc 004565413437 steen.bonnema@rsyd.dk
Contact: Kristian H Winther, MD 004561713854 kristian.winther@rsyd.dk

Locations
Denmark
Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark
Department of Endocrinology and Gastroenterology, Bispebjerg Hospital Not yet recruiting
Copenhagen, Denmark
Department of Internal Medicine, Hospital of South West Denmark Not yet recruiting
Esbjerg, Denmark
Department of Endorcrinology and Metabolism, Odense University Hospital Recruiting
Odense, Denmark
Sponsors and Collaborators
Steen Bonnema
Rigshospitalet, Denmark
Bispebjerg Hospital
Hospital of South West Denmark
Pharma Nord
The Danish Medical Research Council
Region 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

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steen Bonnema, Chief Physician, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02013479     History of Changes
Other Study ID Numbers: DK-CATALYST
Study First Received: December 3, 2013
Last Updated: July 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Thyroiditis
Hashimoto Disease
Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014