Selenium Supplementation in Youths With Autoimmune Thyroiditis (THYROSEL)
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|ClinicalTrials.gov Identifier: NCT02644707|
Recruitment Status : Unknown
Verified December 2015 by Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki.
Recruitment status was: Recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Thyroiditis||Dietary Supplement: L-selenomethionine Other: Placebo||Phase 4|
Background: Selenium in the form of seleno-cysteine is an essential component of enzymes that remove toxic substances from the body, such as glutathione peroxidase (GPX) in thyroid cells as well as seleno-dependent iodothyronine deiodinase that catalyses extra-thyroidal production of triiodothyronine (T3). In general, selenium deficiency may influence production of free radicals, conversion of thyroxine T4 to T3, cytokine production and immune mechanisms. Thus, it has been previously suggested that its supplementation may have a beneficial effect in patients with autoimmune thyroiditis, especially in those with increased inflammatory activity and a higher antibody titer. Although the two studies that have so far been conducted in pediatric populations demonstrated no significant effect of selenium administration on the titre of antibodies, the researchers did administer selenium either in the form of inorganic sodium selenite at the "adult" dose (100-200 mcg daily) or in the form of organic L-selenomethionine at the reduced dose (50 mcg daily). Therefore, to the best of our knowledge, selenium supplementation in the form of organic L-selenomethionine at the "adult" dose (200 mcg daily) has not been investigated in children and adolescents with autoimmune thyroiditis (AT) so far.
Objective: Our aim is to investigate whether the supplementation of organic selenium at the "adult" dose (200 mcg per day in the form of L-selenomethionine) has a favorable impact on thyroid function, including the titer of anti-thyroid antibodies (thyroid-peroxidase antiTPO, and thyroglobulin -antiTg- antibodies), in children and adolescents with autoimmune thyroiditis (AT).
Design and Methods: This is a randomized blinded placebo-controlled clinical trial of selenium supplementation versus placebo in children and adolescents with autoimmune thyroiditis (AT). The trial will include 100 consecutive participants (50 participants in each arm) from the Unit of Pediatric Endocrinology of the 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki, Greece. The patients will be informed and given their written consent to be included in the study. The subjects will then be randomized to receive either organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) or placebo (control group) for 6 months. Both groups will receive oral tablets (one daily), which will be identical in appearance, taste and smell and will differ only in the type of active substance (L-selenomethionine or placebo). Six months of additional follow-up will lead to trial duration of 12 months. The experimental supplement will be given by the Pharmaceutical company marketing the product SEMED200® (INTERMED Pharmaceutical Laboratories). In all participants, determination of the concentrations of thyroid-stimulating hormone (TSH), free thyroxine (fT4), thyroid peroxidase antibodies (TPOAb), thyroglobulin antibody (TgAb) will be made at four times (0, 3, 6 and 12 months). Thyroid volume and morphology will also be sonographically evaluated in three times (0, 6 and 12 months). Serum selenium levels in the form of selenomethionine will also be determined once (at the beginning of the study).
Time-schedule: January- February 2015: protocol preparation. March 2015: first participant's first visit. March 2016: last participant's first visit. September 2016: last participant's last visit. September - October 2016: analysis of biological samples and data, preparation of manuscripts, March 2017: last participant's completion of follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||L-selenomethionine Supplementation in Children and Adolescents With Autoimmune Thyroiditis: a Randomized Blind Placebo-controlled Clinical Trial|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||March 2017|
A group randomized to receive organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) for 6 months
Dietary Supplement: L-selenomethionine
The group will be randomized to receive organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) for 6 months
Placebo Comparator: Placebo
A group randomized to receive placebo (control group) for 6 months
The group will be randomized to receive placebo (control group) for 6 months
- Change in titer of thyroid autoantibodies (thyroid-peroxidase -AntiTPO-, and thyroglobulin -antiTg- antibodies) [ Time Frame: 0,3,6,12 months ]
- Measurement of serum selenium levels [ Time Frame: 0 months ]
- Change in state of thyroid function (Euthyroid or Hypothyroid) [ Time Frame: 0,6,12 months ]Hypothyroid state will be defined as the state of abnormal thyroid function that requires substitution treatment with L-thyroxine; in particular, if thyroid-stimulating hormone (TSH) serum levels are greater than 5 micro-units per milliliter (mcU/ml) and/or the levels of fT4 or fT3 are decreased. Otherwise the state will be considered as euthyroid.
- Change in thyroxine dose per kg per day [ Time Frame: 0,6,12 months ]
- Change in thyroid volume measured by ultrasonography [ Time Frame: 0,6,12 months ]
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): NCT02644707
|Contact: Assimina Galli-Tsinopoulou, Assoc Profemail@example.com|
|Contact: Ioannis Kyrgios, MD, MScfirstname.lastname@example.org|
|Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki||Recruiting|
|Thessaloniki, Greece, 56403|
|Contact: Assimina Galli-Tsinopoulou, Assoc Prof +302310991537 email@example.com|
|Contact: Ioannis Kyrgios, MD,MSc +302310991537 firstname.lastname@example.org|
|Principal Investigator: Assimina Galli-Tsinopoulou, Assoc Prof|
|Sub-Investigator: Ioannis Kyrgios, MD,MSc|
|Sub-Investigator: Eleni P Kotanidou, MD,MSc,PhD|
|Sub-Investigator: Aikaterini Dimopoulou, MD,PhD|
|Sub-Investigator: Angeliki Kleisarchaki, MD|
|Sub-Investigator: Konstantina Mouzaki, MD,MSc|
|Principal Investigator:||Assimina Galli-Tsinopoulou, Assoc Prof||Unit of Pediatric Endocrinology, Diabetes and Metabolism - 4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki, 56403 Thessaloniki, Greece|