Evaluation of the Efficacy of a Supplement With Spirulina for Amelioration of Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Percent Change in Area of Thyroid Nodules
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •suspicion of malignancy / shown
- •autoimmune disease
- •abnormal thyroid function
- •Wilson disease
- •contraception with intrauterine device
结局指标
主要结局
Percent Change in Area of Thyroid Nodules
时间窗: 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
次要结局
未报告次要终点