Status:

COMPLETED

Generic vs. Name-Brand Levothyroxine

Lead Sponsor:

Boston Children's Hospital

Conditions:

Congenital Hypothyroidism

Hypothyroidism

Eligibility:

All Genders

3-18 years

Phase:

NA

Brief Summary

This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Alth...

Detailed Description

This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits ...

Eligibility Criteria

Inclusion

  • Age between 3 and 18 years
  • Diagnosis of Congenital Hypothyroidism with initial TSH \> 100
  • Ability to understand directions and follow all instructions

Exclusion

  • Not on any drug interfering with absorption of levothyroxine

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00403390

Start Date

November 1 2006

End Date

March 1 2010

Last Update

February 23 2018

Active Locations (1)

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1

Children's Hospital Boston

Boston, Massachusetts, United States, 02115