Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)

Condition(s) studied

Investigational drug(s) / intervention(s)

Myo-Inositol 600 mg + Selenium 83 mcg: Myo-Inositol 600 mg + Selenium 83 mcg: 1 tablet once a day for 6 months

Study summary

Thyroid nodules present a variable risk of malignancy depending on the cytological result obtained from the ultrasound-assisted thyroid fine needle aspiration biopsy. According to the Italian Cytology classification SIAPEC-IAP 2014, the TIR3A nodules are indeterminate nodules with a risk of malignancy lower than 10%. Clinical and instrumental follow-up is recommended in these cases, including repetition of the fine needle aspiration.

A study have demonstrate the effect of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of benign thyroid nodules.

Our hypothesis is that the use of this supplement can determine a reduction in the size and consistency of the nodule assessed through ultrasound and elastosonography also in cytologically indeterminate (TIR3A) nodules and that treatment can reduce the cellular proliferation of these nodules assessed by immunocytochemistry.

Therefore, we design a prospective randomized pilot study to assess efficacy and safety of myo-inositol and selenium in TIR3a thyroid nosules, comparing treated and untreated patients.

Eligibility

Primary outcome measure(s)

• Evaluation of differences in elastosonography after six months in patients treated with selenium and myo-inositol and patients not treated (controls) — 6 months
  Changes in elastosonographic score after treatment (comparing treated and untreated patients)- Score varies from 1 (soft) to 4 (hard)

Trial sites (1)

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