NCT00552253

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 22, 2010

Status Verified

December 1, 2010

Enrollment Period

9 months

First QC Date

October 30, 2007

Last Update Submit

December 21, 2010

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • The size of thyroid nodules

    3 months after levothyroxine treatment

Study Arms (1)

1

EXPERIMENTAL

under eltroxin

Drug: Levothyroxin treatment

Interventions

Levothyroxin treatmentDRUG

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

1

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Dou-Liou City, Yun-Lin County, Taiwan

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Shyang-Rong Shi, M.D.

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2007

First Posted

November 1, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 22, 2010

Record last verified: 2010-12

Locations

TW(1)