Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Benign Thyroid Nodule Clinical Trial

— ESSAY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535974
• Other study ID #: TiroNod
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: May 2020
• Source: Fundatia Bio-Forum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 21, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Thyroid Diseases
• Thyroid Nodule

Intervention

Dietary Supplement:
• Preparation with Spirulina
Preparation with Spirulina to ameliorate the size of benign thyroid nodules
• Placebo
Placebo administration for 6 weeks bid

Locations

Country	Name	City	State
Romania	Fundatia Bio-Forum	Bucharest	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Fundatia Bio-Forum

Country where clinical trial is conducted

Romania, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Area of Thyroid Nodules	Size of the thyroid nodules is measured by ultrasound, two perpendicular diameters, same incidence and operator at V1 and V2 Area of nodules is calculated as the product of the two diameters	after 6 weeks of administration of the supplement and placebo