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Levothyroxine Treatment in Thyroid Benign Nodular Goiter
This study is currently recruiting participants.
Study NCT00552253   Information provided by National Taiwan University Hospital
First Received: October 30, 2007   Last Updated: October 31, 2007   History of Changes

October 30, 2007
October 31, 2007
October 2007
 
The size of thyroid nodules [ Time Frame: 3 months after levothyroxine treatment ]
Same as current
Complete list of historical versions of study NCT00552253 on ClinicalTrials.gov Archive Site
 
 
 
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Levothyroxine Treatment in Thyroid Benign Nodular Goiter

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

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.

 
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Thyroid Nodule
Drug: Levothyroxin treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
December 2008
 

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age younger than 20 or older than 90 years old
  2. Pregnancy
  3. Allergy to eltroxin
  4. Taking other drugs which will have drug interaction with eltroxin
  5. patients with cardiovascular disease, hypertension, gastrointestinal disease
Both
20 Years to 90 Years
No
Contact: Shyang-Rong Shi, MD 886-910169628 srshih@ntu.edu.tw
Taiwan
 
NCT00552253
 
200612016M
National Taiwan University Hospital
 
Principal Investigator: Shyang-Rong Shi, M.D. National Taiwan University Hospital Yun-Lin Branch
National Taiwan University Hospital
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP