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

Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients With Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02302768

Enrollment

Registered

2014-11-27

Start date

2012-12-31

Completion date

2015-01-31

Last updated

2014-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroiditis Autoimmune

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.

Interventions

DIETARY_SUPPLEMENTSelenomethionine

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026