Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules (ESSAY)

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Thyroid Nodule
• Intervention / Treatment: Dietary supplement: Preparation with Spirulina; Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 040245
      • Fundatia Bio-Forum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preparation with Spirulina; 6 weeks bid Preparation with Spirulina	Dietary supplement: Preparation with Spirulina; Preparation with Spirulina to ameliorate the size of benign thyroid nodules
Placebo Comparator: Placebo; 6 weeks bid Placebo	Dietary supplement: Placebo; Placebo administration for 6 weeks bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundatia Bio-Forum
• Investigators: Principal Investigator: Corin Badiu, M.D., Institutul Parhon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: TiroNod

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No