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

Study Overview

• Status: Completed
• Conditions: Thyroid Nodule
• Intervention / Treatment: Drug: Levothyroxin treatment

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin County
    • Dou-Liou city, Yun-Lin County, Taiwan
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The size of thyroid nodules	3 months after levothyroxine treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Shyang-Rong Shi, M.D., National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: October 30, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Estimate): December 22, 2010
• Last Update Submitted That Met QC Criteria: December 21, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Goiter; Thyroid Neoplasms; Thyroid Diseases; Goiter, Nodular; Thyroid Nodule
• Other Study ID Numbers: 200612016M