Selenium Supplementation in Autoimmune Thyroiditis
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autoimmune Thyroiditis
Intervention: SelenoPRECISE (Dietary Supplement); Placebo (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Steen Bonnema Official(s) and/or principal investigator(s): Steen J Bonnema, MD, DMSc, Principal Investigator, Affiliation: Odense University Hospital Laszlo Hegedüs, MD, DMSc, Principal Investigator, Affiliation: Odense University Hospital Kristian H Winther, MD, Principal Investigator, Affiliation: Odense University Hospital Torquil Watt, MD, PhD, Principal Investigator, Affiliation: Rigshospitalet, Denmark Per Cramon, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark Ulla Feldt-Rasmussen, MD, DMSc, Principal Investigator, Affiliation: Rigshospitalet, Denmark Åse K Rasmussen, MD, DMSc, Principal Investigator, Affiliation: Rigshospitalet, Denmark Jeppe Gram, MD, PhD, Principal Investigator, Affiliation: Hospital of South West Denmark Nils J Knudsen, MD, DMSc, Principal Investigator, Affiliation: Bispebjerg Hospital, Denmark
Overall contact: Steen J Bonnema, MD, DMSc, Phone: 004565413437, Email: steen.bonnema@rsyd.dk
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.
Clinical Details
Official title: The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Thyroid related quality of life
Secondary outcome: Thyroid peroxidase antibody concentration (TPO-Ab)Levothyroxine (LT4) dosage
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Steen J Bonnema, MD, DMSc, Phone: 004565413437, Email: steen.bonnema@rsyd.dk
Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Recruiting
Department of Endocrinology and Gastroenterology, Bispebjerg Hospital, Copenhagen, Denmark; Not yet recruiting
Department of Internal Medicine, Hospital of South West Denmark, Esbjerg, Denmark; Not yet recruiting
Department of Endorcrinology and Metabolism, Odense University Hospital, Odense, Denmark; Recruiting
Additional Information
Starting date: June 2014
Last updated: April 24, 2015
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