This trial is active, not recruiting.

Condition thyroiditis autoimmune
Treatments selenomethionine, placebo
Phase phase 2
Sponsor University of Siena
Collaborator IBSA Institut Biochimique SA
Start date December 2012
End date January 2014
Trial size 60 participants
Trial identifier NCT02302768, SELENIO 2012


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Placebo Comparator)
Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.
(Active Comparator)
Patients randomized to receive selenomethionine at 80 mcg per day.
(Active Comparator)
Patients randomized to receive selenomethionine at 160 mcg per day.

Primary Outcomes

Reduction of anti-thyroid antibodies
time frame: 12 months
Improvement of thyroid echogenicity
time frame: 12 months

Secondary Outcomes

Prevention or reduction of the incidence of hypothyroidism
time frame: 24 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

Official title 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.
Principal investigator Furio Pacini, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University of Siena.