Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Benign Thyroid Nodule

Intervention / Treatment
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* Dietary Supplement: Preparation with Spirulina
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preparation with Spirulina<br>6 weeks bid Preparation with Spirulina | Dietary Supplement: Preparation with Spirulina<br>* Preparation with Spirulina to ameliorate the size of benign thyroid nodules<br>|
| Placebo Comparator: Placebo<br>6 weeks bid Placebo | Dietary Supplement: Placebo<br>* Placebo administration for 6 weeks bid<br>|

What is the study measuring?
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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 |