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

NCT ID: NCT02302768

Last Updated: 2014-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Thyroiditis Autoimmune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

80-Semet

Patients randomized to receive selenomethionine at 80 mcg per day.

Group Type ACTIVE_COMPARATOR

Selenomethionine

Intervention Type DIETARY_SUPPLEMENT

160-Semet

Patients randomized to receive selenomethionine at 160 mcg per day.

Group Type ACTIVE_COMPARATOR

Selenomethionine

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Selenomethionine

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role collaborator

University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Furio Pacini

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Furio Pacini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Siena

References

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Rayman MP. Selenium and human health. Lancet. 2012 Mar 31;379(9822):1256-68. doi: 10.1016/S0140-6736(11)61452-9. Epub 2012 Feb 29.

Reference Type BACKGROUND
PMID: 22381456 (View on PubMed)

Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14.

Reference Type BACKGROUND
PMID: 24419054 (View on PubMed)

Rotondi M, Chiovato L. The chemokine system as a therapeutic target in autoimmune thyroid diseases: a focus on the interferon-gamma inducible chemokines and their receptor. Curr Pharm Des. 2011;17(29):3202-16. doi: 10.2174/138161211798157559.

Reference Type BACKGROUND
PMID: 21864266 (View on PubMed)

Other Identifiers

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SELENIO 2012

Identifier Type: -

Identifier Source: org_study_id