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临床试验/NCT00552253
NCT00552253已完成不适用

Levothyroxine Treatment in Thyroid Benign Nodular Goiter

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
The size of thyroid nodules

研究概览

简要总结

We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial periods. We will also study the effect of levothyroxin treatment in Chinese people

详细描述

OBJECTIVE - Current treatment of benign thyroid is oral levothyroxin by suppression of thyrotropin secretion and so that tumor growth. Although current consensus is taking thyroxin one hour before meal because the PH value of gastrointestinal tract will affect drug absorption, some patient suffered from epigastric discomfort when taking thyroxin with empty stomach, and wish to take it postprandial. However, there is no direct evidence showing if taking thyroxin at different time point significantly affects treatment outcome. Besides, the response to thyroxin therapy differs among people. The purposes of this study are to evaluate the clinical significance of different time points of thyroxine intake and to search factors relating to thyroxin response of benign thyroid tumors.

RESEARCH DESIGN AND METHODS - We will include patients who have benign thyroid tumors diagnosed with fine needle aspiration cytology and have normal thyroid function into our study. After informed consent, patients will be randomly assigned into two groups. Patients in the first group will take thyroxin one hour before breakfast until thyrotropin level stabilized between 0.5 and 1.0 mU/L for 3 months. Then thyroxin will be discontinued. Patients will restart thyroxin therapy three months later but after breakfast. Patients in another group will take thyroxin postprandial, discontinue thyroxin and then one hour before breakfast. Questionnaire interviews about diet and life style, blood samples and fine needle aspiration cytology samples will be obtained. Changes of thyroid nodules will be evaluated with thyroid echo.

STATISTIC ANALYSIS - Descriptive data will be described as means and SDs for continuous variables, and analysis of variance and Chi-square tests were used for assessing the significances. A p-value below 0.05 was considered significant.

Keywords: benign thyroid tumor, thyroxin, preprandial, postprandial.

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
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 20 to 90 years old
  • Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology

排除标准

  • Age younger than 20 or older than 90 years old
  • Allergy to eltroxin
  • Taking other drugs which will have drug interaction with eltroxin
  • patients with cardiovascular disease, hypertension, gastrointestinal disease

研究组 & 干预措施

1

Experimental

under eltroxin

干预措施: Levothyroxin treatment (Drug)

结局指标

主要结局

The size of thyroid nodules

时间窗: 3 months after levothyroxine treatment

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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