Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules — ESSAY  

Benign Thyroid Nodule Clinical Trial

Official title: Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules

Status Completed

Clinical Trial Summary

Clinical trial with a double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo. Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient. It is expected that a decrease in the thyroid nodules occurs with the supplement administration. Compared with placebo there will be a decrease of at least 20% in the volume or the largest diameter of the nodules during the 6-week administration of the supplement.

Clinical Trial Description

Clinical trial with double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo.

• The sequence of administration supplement - placebo is unknown to the doctor or the patients

• The supplement and placebo are placed in identical capsules and vials by DVR Pharm

• The respective capsules are administered twice a day Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient.

• Echography and blood tests will be performed for each patient initially, after 6 weeks, and after 12 weeks It is expected that a decrease in the thyroid nodules occurs with the supplement administration.

• there will be a direct comparison of the nodules dimensions on the ecographic examinations, in millimeters, and of the blood levels of the molecules which reflect thyroid function ;

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Thyroid Diseases
• Thyroid Nodule

• NCT number: NCT03535974
• Study type: Interventional
• Source: Fundatia Bio-Forum
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Completion date: December 21, 2018