Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

NCT03535974 | Completed Results

• 1 other identifier: TiroNod
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Preparation with Spirulina

ACTIVE COMPARATOR

6 weeks bid Preparation with Spirulina

Dietary Supplement: Preparation with Spirulina

Placebo

PLACEBO COMPARATOR

6 weeks bid Placebo

Dietary Supplement: Placebo

Interventions

Preparation with Spirulina DIETARY_SUPPLEMENT

Preparation with Spirulina to ameliorate the size of benign thyroid nodules

Preparation with Spirulina

Placebo DIETARY_SUPPLEMENT

Placebo administration for 6 weeks bid

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundatia Bio-Forum: lead

Study Sites (1)

Fundatia Bio-Forum

Bucharest, București, 040245, Romania

Location

Related 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.

  PMID: 31322200 BACKGROUND

Results Point of Contact

• Title: Dr. Felician Stancioiu
• Organization: Fundatia Bio-Forum

felicians11@gmail.com

+40727500402

Study Officials

• Corin Badiu, M.D.

  Institutul Parhon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 24, 2018
• Study Start: May 15, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 21, 2018
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)