Salenio: clinical study design

Abstract

In the last 20 years there has been a marked increase in thyroid disease, although partly due to increased attention to screening, possibilities for more extensive and more sensitive laboratory diagnostic tests, and the availability of more advanced imaging technologies, nevertheless appears to be evidence of a profound dietary, biological, and environmental change.1,2 Autoimmune thyroiditis is the most frequent cause of hypothyroidism in iodinereplete populations.3 It is now estimated that 1/3 of the female population and 1/8 of the male population in goitrogenic endemic countries such as ours, have thyroid disease, and of these 80% are autoimmune thyroiditis. The complexity of this phenomenon is certainly partly due to the extreme thyroid sensitivity to ionizing radiation,4 but it can also be explained by nutritional deficiency of other factors such as Iodine and Selenium:5 the therapy of these patients is increasingly focused on the use of dietary supplements of Iodine and Selenium, meanwhile the latest international guidelines6 are increasingly scaling back the use of thyroid hormone (L-Tyroxine) in this huge plethora of patients in normofunctioning patients with nodular thyroidopathy and patients with subclinical hypothyroidism.7,8 This leaves on the market a sizeable slice of patients receptive to Iodine and Selenium treatments; our research aims precisely to test in these patients the efficacy of a salt that is already supplemented with Iodine and Selenium, comparing it in a double-blind randomized trial with a control group using neither iodized salt nor supplements, a group using iodized salt and a Selenium supplement, and finally a third group using an Iodine and Selenium supplement.