Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Primary Purpose
Thyroid Nodule
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Levothyroxin treatment
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- age between 20 to 90 years old
- Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology
Exclusion Criteria:
- Age younger than 20 or older than 90 years old
- Pregnancy
- Allergy to eltroxin
- Taking other drugs which will have drug interaction with eltroxin
- patients with cardiovascular disease, hypertension, gastrointestinal disease
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
under eltroxin
Outcomes
Primary Outcome Measures
The size of thyroid nodules
Secondary Outcome Measures
Full Information
NCT ID
NCT00552253
First Posted
October 30, 2007
Last Updated
December 21, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00552253
Brief Title
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Official Title
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
under eltroxin
Intervention Type
Drug
Intervention Name(s)
Levothyroxin treatment
Intervention Description
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 Measure Information:
Title
The size of thyroid nodules
Time Frame
3 months after levothyroxine treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 20 to 90 years old
Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology
Exclusion Criteria:
Age younger than 20 or older than 90 years old
Pregnancy
Allergy to eltroxin
Taking other drugs which will have drug interaction with eltroxin
patients with cardiovascular disease, hypertension, gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyang-Rong Shi, M.D.
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Dou-Liou city
State/Province
Yun-Lin County
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
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