Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT

NCT02302768 | Unknown Phase 2

• 1 other identifier: SELENIO 2012
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.

Conditions

Thyroiditis Autoimmune

Outcome Measures

Primary Outcomes (2)

• Reduction of anti-thyroid antibodies

  Anti thyroperoxidase and thyroglobulin antibodies are measured by a chemiluminescent assay. Any statistically significant decrease of one or both antibody values compared to the baseline is considered a reduction relevant to the study outcome.

  12 months

• Improvement of thyroid echogenicity

  High-resolution sonograhic images are captured, converted into a spectrum of gray-scale pixels (gsp) ranging from 0 (lowest echogenicity) to 255 (highest echogenicity) and a mean value is then obtained. Any statistically significant increase of the gsp compared to the baseline is considered an improvement relevant to the study outcome.

  12 months

Secondary Outcomes (1)

• Prevention or reduction of the incidence of hypothyroidism

  24 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.

Other: Placebo

80-Semet

ACTIVE COMPARATOR

Patients randomized to receive selenomethionine at 80 mcg per day.

Dietary Supplement: Selenomethionine

160-Semet

ACTIVE COMPARATOR

Patients randomized to receive selenomethionine at 160 mcg per day.

Dietary Supplement: Selenomethionine

Interventions

Selenomethionine DIETARY_SUPPLEMENT

160-Semet; 80-Semet

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (\> or = 100 U/l) and thyroid hypoechogenicity

You may not qualify if:

• Presence of other thyroid disease but micronodules
• History of the malignancy in the past 5 years
• Drugs affecting immune system and/or thyroid function
• Pregnancy detected during screening or follow-up.

Sponsors & Collaborators

• University of Siena: lead
• IBSA Institut Biochimique SA: collaborator

Related Publications (3)

• Rayman MP. Selenium and human health. Lancet. 2012 Mar 31;379(9822):1256-68. doi: 10.1016/S0140-6736(11)61452-9. Epub 2012 Feb 29.

  PMID: 22381456 BACKGROUND

• Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14.

  PMID: 24419054 BACKGROUND

• Rotondi M, Chiovato L. The chemokine system as a therapeutic target in autoimmune thyroid diseases: a focus on the interferon-gamma inducible chemokines and their receptor. Curr Pharm Des. 2011;17(29):3202-16. doi: 10.2174/138161211798157559.

  PMID: 21864266 BACKGROUND

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Selenomethionine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organoselenium Compounds; Organic Chemicals; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Furio Pacini, MD

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 27, 2014
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 27, 2014

Record last verified: 2014-11