Levothyroxine Treatment in Thyroid Benign Nodular Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552253
Recruitment Status : Completed
First Posted : November 1, 2007
Last Update Posted : December 22, 2010
Information provided by:
National Taiwan University Hospital

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

Condition or disease Intervention/treatment Phase
Thyroid Nodule Drug: Levothyroxin treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: 1
under eltroxin
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

Primary Outcome Measures :
  1. The size of thyroid nodules [ Time Frame: 3 months after levothyroxine treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552253

National Taiwan University Hospital
Dou-Liou city, Yun-Lin County, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Shyang-Rong Shi, M.D. National Taiwan University Hospital, Yun-Lin Branch

Responsible Party: Shyang-Rong, Shih, MD, National Taiwan University Hospital, Internal Medicine Identifier: NCT00552253     History of Changes
Other Study ID Numbers: 200612016M
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Goiter, Nodular
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms