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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02302768
Recruitment Status : Unknown
Verified November 2014 by Furio Pacini, University of Siena.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2014
Last Update Posted : November 27, 2014
IBSA Institut Biochimique SA
Information provided by (Responsible Party):
Furio Pacini, 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.

Condition or disease Intervention/treatment Phase
Thyroiditis Autoimmune Dietary Supplement: Selenomethionine Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : December 2012
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : January 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.
Other: Placebo
Active Comparator: 80-Semet
Patients randomized to receive selenomethionine at 80 mcg per day.
Dietary Supplement: Selenomethionine
Active Comparator: 160-Semet
Patients randomized to receive selenomethionine at 160 mcg per day.
Dietary Supplement: Selenomethionine

Primary Outcome Measures :
  1. Reduction of anti-thyroid antibodies [ Time Frame: 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.

  2. Improvement of thyroid echogenicity [ Time Frame: 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 Outcome Measures :
  1. Prevention or reduction of the incidence of hypothyroidism [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02302768

Sponsors and Collaborators
University of Siena
IBSA Institut Biochimique SA
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Principal Investigator: Furio Pacini, MD University of Siena
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Responsible Party: Furio Pacini, Full Professor, University of Siena Identifier: NCT02302768    
Other Study ID Numbers: SELENIO 2012
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: November 27, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances