Clinical trial NCT03535974: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Thyroid Nodule
Lead sponsor: Fundatia Bio-Forum
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* euthyroid adults (normal TSH)
* no criteria for malignancy is present (size, fine needle aspiration, lymph nodules)
* no other medication/supplement administered for thyroid, no steroids, beta-blocker

Exclusion Criteria:

* suspicion of malignancy / shown
* autoimmune disease
* abnormal thyroid function
* Wilson disease
* contraception with intrauterine device

Primary outcomes:
measure: Percent Change in Area of Thyroid Nodules
timeFrame: after 6 weeks of administration of the supplement and placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundatia Bio-Forum
state: Bucuresti
Study officials:
affiliation: Institutul Parhon
name: Corin Badiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stancioiu F, Mihai D, Papadakis GZ, Tsatsakis A, Spandidos DA, Badiu C. Treatment for benign thyroid nodules with a combination of natural extracts. Mol Med Rep. 2019 Sep;20(3):2332-2338. doi: 10.3892/mmr.2019.10453. Epub 2019 Jul 1.