NCT03535974

Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Fundatia Bio-Forum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Benign Thyroid Nodule

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Preparation with Spirulina	Preparation with Spirulina to ameliorate the size of benign thyroid nodules
DIETARY_SUPPLEMENT	Placebo	Placebo administration for 6 weeks bid

Timeline

• Start date: 2018-05-15
• Primary completion: 2018-12-20
• Completion: 2018-12-21
• First posted: 2018-05-24
• Last updated: 2020-05-19
• Results posted: 2020-05-19

Locations

1 site across 1 country: Romania