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OpenTrials
Completed

NCT Number: NCT03535974

Efficacy of a Spirulina Supplement 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundatia Bio-Forum

Bucharest, 040245, Romania

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preparation with Spirulina

Dietary Supplement

Preparation with Spirulina to ameliorate the size of benign thyroid nodules

Placebo

Dietary Supplement

Placebo administration for 6 weeks bid

Primary outcomes

  1. Percent Change in Area of Thyroid Nodules

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundatia Bio-Forum

Other

Registry information

Official study title

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

Acronym: ESSAY

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 24, 2018
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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