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| Tracking Information | |||||
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| First Received Date ICMJE | October 30, 2007 | ||||
| Last Updated Date | October 31, 2007 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
The size of thyroid nodules [ Time Frame: 3 months after levothyroxine treatment ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00552253 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Levothyroxine Treatment in Thyroid Benign Nodular Goiter | ||||
| Official Title ICMJE | Levothyroxine Treatment in Thyroid Benign Nodular Goiter | ||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment | ||||
| Condition ICMJE | Thyroid Nodule | ||||
| Intervention ICMJE | Drug: Levothyroxin treatment | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | December 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00552253 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 200612016M | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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