Generic vs. Name-Brand Levothyroxine

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital

Criteria

Inclusion Criteria:

• Age between 3 and 18 years

• Diagnosis of Congenital Hypothyroidism with initial TSH > 100

• Ability to understand directions and follow all instructions

Exclusion Criteria:

• Not on any drug interfering with absorption of levothyroxine