Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
IBSA Institut Biochimique SA
Information provided by (Responsible Party):
Furio Pacini, University of Siena

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 27, 2014
Last Update Posted Date November 27, 2014
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Thyroiditis Autoimmune
Intervention  ICMJE
  • Dietary Supplement: Selenomethionine
  • Other: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Other: Placebo
  • Active Comparator: 80-Semet
    Patients randomized to receive selenomethionine at 80 mcg per day.
    Intervention: Dietary Supplement: Selenomethionine
  • Active Comparator: 160-Semet
    Patients randomized to receive selenomethionine at 160 mcg per day.
    Intervention: Dietary Supplement: Selenomethionine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 26, 2014)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02302768
Other Study ID Numbers  ICMJE SELENIO 2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Furio Pacini, University of Siena
Study Sponsor  ICMJE University of Siena
Collaborators  ICMJE IBSA Institut Biochimique SA
Investigators  ICMJE
Principal Investigator: Furio Pacini, MD University of Siena
PRS Account University of Siena
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP