Title
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules
Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules
Phase
N/ALead Sponsor
Fundatia Bio-ForumStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Benign Thyroid NoduleIntervention/Treatment
spirulina ...Study Participants
38Clinical 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.
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
Preparation with Spirulina to ameliorate the size of benign thyroid nodules
Placebo administration for 6 weeks bid
6 weeks bid Preparation with Spirulina
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
| Event Type | Organ System | Event Term | Preparation With Spirulina | 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
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
