MedTrace Logo

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

NCT02302768 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-11-27

No results posted yet for this study

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.

Conditions

  • Thyroiditis Autoimmune

Interventions

DIETARY_SUPPLEMENT

Selenomethionine

OTHER

Placebo

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    collaborator INDUSTRY

  • University of Siena

    lead OTHER

Principal Investigators

  • Furio Pacini, MD · University of Siena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2015-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302768 on ClinicalTrials.gov