Selenium Supplementation in Youths With Autoimmune Thyroiditis

NCT02644707 | Completed Phase 4

• 1 other identifier: ARISTOTLE UNIVERSITY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Autoimmune Thyroiditis

Outcome Measures

Primary Outcomes (1)

• Change in titer of thyroid autoantibodies (thyroid-peroxidase -AntiTPO-, and thyroglobulin -antiTg- antibodies)

  0,3,6,12 months

Secondary Outcomes (4)

• Measurement of serum selenium levels

  0 months

• Change in state of thyroid function (Euthyroid or Hypothyroid)

  0,6,12 months

• Change in thyroxine dose per kg per day

  0,6,12 months

• Change in thyroid volume measured by ultrasonography

  0,6,12 months

Study Arms (2)

L-selenomethionine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

A group randomized to receive placebo (control group) for 6 months

Other: Placebo

Interventions

L-selenomethionine DIETARY_SUPPLEMENT

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

L-selenomethionine

Placebo OTHER

The group will be randomized to receive placebo (control group) for 6 months

Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, 56403, Greece

Location

Related Publications (15)

• Karanikas G, Schuetz M, Kontur S, Duan H, Kommata S, Schoen R, Antoni A, Kletter K, Dudczak R, Willheim M. No immunological benefit of selenium in consecutive patients with autoimmune thyroiditis. Thyroid. 2008 Jan;18(1):7-12. doi: 10.1089/thy.2007.0127.

  PMID: 18302514 BACKGROUND

• Anastasilakis AD, Toulis KA, Nisianakis P, Goulis DG, Kampas L, Valeri RM, Oikonomou D, Tzellos TG, Delaroudis S. Selenomethionine treatment in patients with autoimmune thyroiditis: a prospective, quasi-randomised trial. Int J Clin Pract. 2012 Apr;66(4):378-83. doi: 10.1111/j.1742-1241.2011.02879.x. Epub 2012 Feb 22.

  PMID: 22356267 RESULT

• Bonfig W, Gartner R, Schmidt H. Selenium supplementation does not decrease thyroid peroxidase antibody concentration in children and adolescents with autoimmune thyroiditis. ScientificWorldJournal. 2010 Jun 1;10:990-6. doi: 10.1100/tsw.2010.91.

  PMID: 20526530 RESULT

• Duntas LH, Mantzou E, Koutras DA. Effects of a six month treatment with selenomethionine in patients with autoimmune thyroiditis. Eur J Endocrinol. 2003 Apr;148(4):389-93. doi: 10.1530/eje.0.1480389.

  PMID: 12656658 RESULT

• Eskes SA, Endert E, Fliers E, Birnie E, Hollenbach B, Schomburg L, Kohrle J, Wiersinga WM. Selenite supplementation in euthyroid subjects with thyroid peroxidase antibodies. Clin Endocrinol (Oxf). 2014 Mar;80(3):444-51. doi: 10.1111/cen.12284. Epub 2013 Jul 31.

  PMID: 23844613 RESULT

• Gartner R, Gasnier BC, Dietrich JW, Krebs B, Angstwurm MW. Selenium supplementation in patients with autoimmune thyroiditis decreases thyroid peroxidase antibodies concentrations. J Clin Endocrinol Metab. 2002 Apr;87(4):1687-91. doi: 10.1210/jcem.87.4.8421.

  PMID: 11932302 RESULT

• Krysiak R, Okopien B. The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2011 Jul;96(7):2206-15. doi: 10.1210/jc.2010-2986. Epub 2011 Apr 20.

  PMID: 21508145 RESULT

• Mazokopakis EE, Papadakis JA, Papadomanolaki MG, Batistakis AG, Giannakopoulos TG, Protopapadakis EE, Ganotakis ES. Effects of 12 months treatment with L-selenomethionine on serum anti-TPO Levels in Patients with Hashimoto's thyroiditis. Thyroid. 2007 Jul;17(7):609-12. doi: 10.1089/thy.2007.0040.

  PMID: 17696828 RESULT

• Nacamulli D, Mian C, Petricca D, Lazzarotto F, Barollo S, Pozza D, Masiero S, Faggian D, Plebani M, Girelli ME, Mantero F, Betterle C. Influence of physiological dietary selenium supplementation on the natural course of autoimmune thyroiditis. Clin Endocrinol (Oxf). 2010 Oct;73(4):535-9. doi: 10.1111/j.1365-2265.2009.03758.x.

  PMID: 20039895 RESULT

• Negro R, Greco G, Mangieri T, Pezzarossa A, Dazzi D, Hassan H. The influence of selenium supplementation on postpartum thyroid status in pregnant women with thyroid peroxidase autoantibodies. J Clin Endocrinol Metab. 2007 Apr;92(4):1263-8. doi: 10.1210/jc.2006-1821. Epub 2007 Feb 6.

  PMID: 17284630 RESULT

• Onal H, Keskindemirci G, Adal E, Ersen A, Korkmaz O. Effects of selenium supplementation in the early stage of autoimmune thyroiditis in childhood: an open-label pilot study. J Pediatr Endocrinol Metab. 2012;25(7-8):639-44. doi: 10.1515/jpem-2012-0078.

  PMID: 23155687 RESULT

• Toulis KA, Anastasilakis AD, Tzellos TG, Goulis DG, Kouvelas D. Selenium supplementation in the treatment of Hashimoto's thyroiditis: a systematic review and a meta-analysis. Thyroid. 2010 Oct;20(10):1163-73. doi: 10.1089/thy.2009.0351.

  PMID: 20883174 RESULT

• Turker O, Kumanlioglu K, Karapolat I, Dogan I. Selenium treatment in autoimmune thyroiditis: 9-month follow-up with variable doses. J Endocrinol. 2006 Jul;190(1):151-6. doi: 10.1677/joe.1.06661.

  PMID: 16837619 RESULT

• van Zuuren EJ, Albusta AY, Fedorowicz Z, Carter B, Pijl H. Selenium supplementation for Hashimoto's thyroiditis. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD010223. doi: 10.1002/14651858.CD010223.pub2.

  PMID: 23744563 RESULT

• Zhu L, Bai X, Teng WP, Shan ZY, Wang WW, Fan CL, Wang H, Zhang HM. [Effects of selenium supplementation on antibodies of autoimmune thyroiditis]. Zhonghua Yi Xue Za Zhi. 2012 Aug 28;92(32):2256-60. Chinese.

  PMID: 23158484 RESULT

MeSH Terms

Conditions

Thyroiditis, Autoimmune

Interventions

Selenium

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSSOCIATE PROFESSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 1, 2016
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: August 1, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)