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Brief Title: Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Official Title: Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules
Study ID: NCT03535974
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fundatia Bio-Forum, Bucharest, Bucuresti, Romania
Name: Corin Badiu, M.D.
Affiliation: Institutul Parhon
Role: PRINCIPAL_INVESTIGATOR