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

University of Siena

Status and phase: Unknown; Phase 2

Conditions: Thyroiditis Autoimmune

Treatments: Dietary Supplement: Selenomethionine; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02302768

SELENIO 2012

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

80-Semet

Active Comparator group

Description:

Patients randomized to receive selenomethionine at 80 mcg per day.

Treatment:

Dietary Supplement: Selenomethionine

160-Semet

Active Comparator group

Description:

Patients randomized to receive selenomethionine at 160 mcg per day.

Treatment:

Dietary Supplement: Selenomethionine