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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00552253 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Thyroid Nodule |
Drug: Levothyroxin treatment |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment |
| Official Title: | Levothyroxine Treatment in Thyroid Benign Nodular Goiter |
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Levothyroxin treatment
Levothyroxin 100 micogram will be administered once daily 1 hour before meal of just after meal for 3 months, and the dose will be titrate to keep serum TSH level between 0.1~0.3 mU/L. It will be discontinued for 3 months. Then
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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.
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shyang-Rong Shi, MD | 886-910169628 | srshih@ntu.edu.tw |
| Taiwan, Yun-Lin County | |
| National Taiwan University Hospital Yun-Lin Branch | Recruiting |
| Dou-Liou city, Yun-Lin County, Taiwan | |
| Contact: Shyang-Rong Shi, MD 886-910169628 srshih@ntu.edu.tw | |
| Principal Investigator: | Shyang-Rong Shi, M.D. | National Taiwan University Hospital Yun-Lin Branch |
More Information
| Study ID Numbers: | 200612016M |
| Study First Received: | October 30, 2007 |
| Last Updated: | October 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00552253 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Neoplasms Goiter Neoplasms by Site Thyroid Neoplasms Thyroid Nodule |
Head and Neck Neoplasms Endocrine System Diseases Goiter, Nodular Thyroid Diseases Endocrine Gland Neoplasms |