NCT03535974: ESSAY

Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Completed NA Results posted Last updated 19 May 2020

What this trial tests

NA trial testing Preparation with Spirulina in Benign Thyroid Nodule in 38 participants. Completed in 21 December 2018.

Timeline

15 May 2018

Primary endpoint
20 December 2018

21 December 2018

Quick facts

Lead sponsor	Fundatia Bio-Forum
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	15 May 2018
Primary completion	20 December 2018
Estimated completion	21 December 2018
Sites	1 location across Romania

Drugs / interventions tested

• Preparation with Spirulina
• Placebo

Conditions studied

• Benign Thyroid Nodule — all drugs for Benign Thyroid Nodule →

Sponsor

Fundatia Bio-Forum

Who can join

18 and older, any sex, with Benign Thyroid Nodule. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in Area of Thyroid Nodules Primary · after 6 weeks of administration of the supplement and placebo

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

Group	Value	95% CI
Preparation With Spirulina	-19.98	± 15.55
Placebo	-9.31	± 14.29

Mean Change in Nodule Areas, All Administrations of 6 Weeks Each (n=68), AI (n=39) Versus P (n=29) Secondary · after 12 weeks of administration of the supplement and placebo

Mean modification in the area of the nodules in cm\^2, calculated as the difference between the initial and final nodule area after 6 weeks of administration of either AI (total 39 administrations) or P (total 29 administrations), and standard deviation

Group	Value	95% CI
All AI Administrations (n=39)	0.611	± 0.933
All P Administrations (n=29)	0.178	± 0.515

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preparation With Spirulina

Serious: 0/34 (0%)

Deaths: 0/34

Placebo

Serious: 1/29 (3%)

Deaths: 0/29

Serious adverse events (1 terms)

Reaction	System	Preparation With Spirulina	Placebo
allergic reaction while on placebo	Immune system disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Preparation With Spirulina	Placebo
allergic reaction while on placebo	Immune system disorders	—	—

Most-reported serious reactions: allergic reaction while on placebo.

Data from ClinicalTrials.gov NCT03535974 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment for benign thyroid nodules with a combination of natural extracts.
   Stancioiu F, Mihai D, Papadakis GZ, Tsatsakis A, et al · · 2019 · cited 19× · PMID 31322200 · DOI 10.3892/mmr.2019.10453
2. Algae-Derived Bioactive Compounds as Platforms for Translational Biotechnology and Health Applications.
   Morris H, Coombes Z, El Dor Z, Rodrigues VJ, et al · · 2026 · PMID 42200944 · DOI 10.3390/biotech15020034