Selenium Supplementation in Youths With Autoimmune Thyroiditis (THYROSEL)

January 31, 2020 updated by: Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

L-selenomethionine Supplementation in Children and Adolescents With Autoimmune Thyroiditis: a Randomized Blind Placebo-controlled Clinical Trial

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 [Anti-thyroid peroxidase (anti-TPO) and Anti-thyroglobulin (anti-Tg) antibodies], in children and adolescents with autoimmune thyroiditis (AT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56403
        • Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: A positive titer of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies (TPO and / or Tg> 60 IU / ml) and at least one of:

  • Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 micro-units per milliliter (mcU/ml) and decreased or normal levels of fT4 or fT3)
  • Increased volume of thyroid gland (goiter)
  • Morphological changes on ultrasound of the thyroid gland

Exclusion Criteria:

  • Presence of another chronic disease or autoimmune disease or being under medication
  • Age of diagnosis above 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-selenomethionine
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
Other: Placebo
The group will be randomized to receive placebo (control group) for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in titer of thyroid autoantibodies (thyroid-peroxidase -AntiTPO-, and thyroglobulin -antiTg- antibodies)
Time Frame: 0,3,6,12 months
0,3,6,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of serum selenium levels
Time Frame: 0 months
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.
0,6,12 months
Change in thyroxine dose per kg per day
Time Frame: 0,6,12 months
0,6,12 months
Change in thyroid volume measured by ultrasonography
Time Frame: 0,6,12 months
0,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARISTOTLE UNIVERSITY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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