An interventional study of Brand Name Levothyroxine (Synthroid) and Generic formulation of Levothyroxine in Congenital Hypothyroidism and Hypothyroidism, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
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 over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.
26 studies on the registry are indexed under Congenital Hypothyroidism; 9 are open to participants now.
Browse Congenital Hypothyroidism studies →Boston Children's Hospital is the lead sponsor of 607 studies on the registry; 148 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.
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Exclusion Criteria:
Dose previously demonstrated to normalize thyroid function given daily for 2 months
Drug: Brand Name Levothyroxine (Synthroid)
Dosage previously determined to normalize thyroid function given daily for 2 months
Drug: Generic formulation of Levothyroxine
Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.
Also known as: Levothyroxine
Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.
Also known as: No other names
Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.
Time frame: 3 points over 16 weeks
Subjects were recruited through flyers in the endocrine clinic and letters with opt-out cards to contact. Recruitment started November 2006 and completed ended March 2010.
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 16 | 18 |
| Completed | 13 | 18 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Samples lost | 1 | 0 |
| Withdrew: Non-compliant | 1 | 0 |
| uIU/mL | Group 1 | Group 2 |
|---|---|---|
| Baseline | 2.455 ± 1.532 | 2.131 ± 1.322 |
| After first drug | 0.788 ± 0.631 | 3.053 ± 1.233 |
| After second drug | 3.112 ± 4.983 | 1.217 ± 2.832 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Group 2 | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| <=18 years | 13 | 18 | 31 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 10 ± 1.2 | 10 ± 1.0 | 10 ± 1.1 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 9 | 15 | 24 |
| Male | 4 | 3 | 7 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| United States | 13 | 18 | 31 |
Plan to share: No — Nothing currently planned
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Thyroxine