Levothyroxine Treatment in Thyroid Benign Nodular Goiter

Thyroid Nodule Clinical Trial

Official title:

Levothyroxine Treatment in Thyroid Benign Nodular Goiter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552253
• Other study ID #: 200612016M
• Status: Completed
• Phase: N/A
• First received: October 30, 2007
• Last updated: December 21, 2010
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: December 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter, Nodular
• Thyroid Diseases
• Thyroid Nodule

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Dou-Liou city	Yun-Lin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The size of thyroid nodules		3 months after levothyroxine treatment	No