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

Primary Purpose

Thyroiditis Autoimmune

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Selenomethionine
Placebo
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroiditis Autoimmune

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    80-Semet

    160-Semet

    Arm Description

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

    Patients randomized to receive selenomethionine at 80 mcg per day.

    Patients randomized to receive selenomethionine at 160 mcg per day.

    Outcomes

    Primary Outcome Measures

    Reduction of anti-thyroid antibodies
    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
    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

    Prevention or reduction of the incidence of hypothyroidism
    Defined by a significant lower number of new subclinical or overt hypothyroidism cases in the two Semet groups compared to the placebo group.

    Full Information

    First Posted
    November 20, 2014
    Last Updated
    November 26, 2014
    Sponsor
    University of Siena
    Collaborators
    IBSA Institut Biochimique SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02302768
    Brief Title
    Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Siena
    Collaborators
    IBSA Institut Biochimique SA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroiditis Autoimmune

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients randomized to receive same pharmaceutical form (capsule) used for the two Semet groups, with the same excipients but the active drug.
    Arm Title
    80-Semet
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to receive selenomethionine at 80 mcg per day.
    Arm Title
    160-Semet
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to receive selenomethionine at 160 mcg per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Selenomethionine
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Reduction of anti-thyroid antibodies
    Description
    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.
    Time Frame
    12 months
    Title
    Improvement of thyroid echogenicity
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Prevention or reduction of the incidence of hypothyroidism
    Description
    Defined by a significant lower number of new subclinical or overt hypothyroidism cases in the two Semet groups compared to the placebo group.
    Time Frame
    24 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Furio Pacini, MD
    Organizational Affiliation
    University of Siena
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22381456
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24419054
    Citation
    Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14.
    Results Reference
    background
    PubMed Identifier
    21864266
    Citation
    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.
    Results Reference
    background

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

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