Thyroiditis Autoimmune Clinical Trial
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.
| Verified date | November 2014 |
| Source | University of Siena |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Siena | IBSA Institut Biochimique SA |
Nacamulli D, Petricca D, Mian C. Selenium and autoimmune thyroiditis. J Endocrinol Invest. 2013 Nov;36(10 Suppl):8-14. — View 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. Review. — View Citation
Rotondi M, Chiovato L. The chemokine system as a therapeutic target in autoimmune thyroid diseases: a focus on the interferon-? inducible chemokines and their receptor. Curr Pharm Des. 2011;17(29):3202-16. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 12 months | No |
| Primary | 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. | 12 months | No |
| Secondary | 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. | 24 months | No |