Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- thyroid-symptom questionnaire
研究概览
简要总结
Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months.
排除标准
- •Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old.
- •Patients scheduled for deployment will be excluded.
研究组 & 干预措施
Levothyroxine
Levothyroxine in the capsule form, once daily, appropriate dosage to keep TSH at the normal range.
干预措施: Desiccated thyroid extract (Drug)
Desiccated thyroid extract
Desiccated thyroid extract in capsule form, once daily, appropriate dosage to keep TSH in the normal range.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
thyroid-symptom questionnaire
时间窗: 4 months
Thyroid Symptom Questionnaire, a health-related quality-of-life questionnaire, that consists of 12 questions, presented in the same format as the GHQ-12, that asked patients how they felt over the last three months.
Wechsler Memory Scale-Version IV (WMS-IV)
时间窗: 4 months
The Wechsler Memory Scale-Version IV (WMS-IV) included auditory memory index, visual memory index, visual working memory index, immediate memory index and delayed memory index.
次要结局
- Biochemical measures(4 months)
研究者
Mohamed K.M. Shakir
Principal Investigator
Walter Reed National Military Medical Center