Selenium Supplementation in Autoimmune Thyroiditis (CATALYST)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02013479 |
|
Recruitment Status :
Recruiting
First Posted : December 17, 2013
Last Update Posted : August 30, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autoimmune Thyroiditis | Dietary Supplement: SelenoPRECISE Dietary Supplement: Placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 472 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 : | January 2020 |
| Estimated Study Completion Date : | February 2021 |
| 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 |
- Thyroid related quality of life [ Time Frame: 12 months after initation of intervention ]Measured in composite score based on the ThyPRO questionnaire
- Thyroid peroxidase antibody concentration (TPO-Ab) [ Time Frame: 12 months after initation of intervention ]
- Levothyroxine (LT4) dosage [ Time Frame: 12 months after initation of intervention ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013479
| Contact: Steen J Bonnema, MD, DMSc | 004565413437 | steen.bonnema@rsyd.dk | |
| Contact: Kristian H Winther, MD | 004561713854 | kristian.winther@rsyd.dk |
| 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 | |
| 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 |
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 |
| First Posted: | December 17, 2013 Key Record Dates |
| Last Update Posted: | August 30, 2019 |
| Last Verified: | August 2019 |
|
Thyroiditis Thyroiditis, Autoimmune Hashimoto Disease Thyroid Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Selenium |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Trace Elements Micronutrients Nutrients Growth Substances |