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Trial record 12 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

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
Sponsor:
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Autoimmune Thyroiditis Dietary Supplement: L-selenomethionine Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


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




Primary Outcome Measures :
  1. Change in titer of thyroid autoantibodies (thyroid-peroxidase -AntiTPO-, and thyroglobulin -antiTg- antibodies) [ Time Frame: 0,3,6,12 months ]

Secondary Outcome Measures :
  1. Measurement of serum selenium levels [ Time Frame: 0 months ]
  2. 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.

  3. Change in thyroxine dose per kg per day [ Time Frame: 0,6,12 months ]
  4. Change in thyroid volume measured by ultrasonography [ Time Frame: 0,6,12 months ]


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Assimina Galli-Tsinopoulou, Assoc Prof +302310991537 agalli@auth.gr
Contact: Ioannis Kyrgios, MD, MSc +302310991537 ikyrgios@yahoo.gr

Locations
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Greece
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    agalli@auth.gr   
Contact: Ioannis Kyrgios, MD,MSc    +302310991537    ikyrgios@yahoo.gr   
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         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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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 of Results:

Other Publications:
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Responsible Party: Assimina Galli-Tsinopoulou, ASSSOCIATE PROFESSOR, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02644707     History of Changes
Other Study ID Numbers: ARISTOTLE UNIVERSITY
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hashimoto Disease
Thyroiditis
Thyroiditis, Autoimmune
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