Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With Overt Hypothyroidism
研究概览
简要总结
The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low thyroid hormone levels).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Levothyroxine
In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.
干预措施: Levothyroxine (Drug)
Placebo
In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Overt Hypothyroidism
时间窗: 8 weeks
Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result \> 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) \< 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.
次要结局
- Change in Hypothyroid-Health Related Quality of Life(4 weeks, 8 weeks)
- Change in Thyroid Specific Quality of Life(4 weeks, 8 weeks)
研究者
Marius Stan
Associate Professor of Medicine, Endocrinology Consultant
Mayo Clinic