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

Phase 2

• Conditions: Thyroiditis Autoimmune
• Interventions: Dietary Supplement: Selenomethionine; Other: Placebo

• Registration Number: NCT02302768
• Lead Sponsor: University of Siena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-01
• Status Verified: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Study First Posted: 2014-11-27
• Last Update Posted: 2014-11-27
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
80-Semet	Selenomethionine	Patients randomized to receive selenomethionine at 80 mcg per day.
160-Semet	Selenomethionine	Patients randomized to receive selenomethionine at 160 mcg per day.
Placebo	Placebo	Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.

Primary Outcome Measures

Name	Time	Method
Improvement of thyroid echogenicity	12 months	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.
Reduction of anti-thyroid antibodies	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Prevention or reduction of the incidence of hypothyroidism	24 months	Defined by a significant lower number of new subclinical or overt hypothyroidism cases in the two Semet groups compared to the placebo group.