Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
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|ClinicalTrials.gov Identifier: NCT02374593|
Recruitment Status : Completed
First Posted : March 2, 2015
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Hypothyroidism||Drug: Levothyroxine Device: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Targeted dosing
Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.
- Dose Adjustments [ Time Frame: 6 months ]Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.
- Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls [ Time Frame: 6 months ]Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374593
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Erica Eugster, MD||Indiana University|