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

Fundatia Bio-Forum

Status: Completed

Conditions: Benign Thyroid Nodule

Treatments: Dietary Supplement: Preparation with Spirulina; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03535974

TiroNod

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Preparation with Spirulina

Active Comparator group

Description:

6 weeks bid Preparation with Spirulina

Treatment:

Dietary Supplement: Preparation with Spirulina

Placebo

Placebo Comparator group

Description:

6 weeks bid Placebo

Treatment:

Dietary Supplement: Placebo