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Trial record 1 of 11 for:    Congenital Hypothyroidism
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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
Sponsor:
Information provided by (Responsible Party):
Erica Eugster, Indiana University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Congenital Hypothyroidism
Interventions Drug: Levothyroxine
Device: Ultrasound
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Targeted Dosing Historical Control
Hide Arm/Group Description 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. Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
Period Title: Overall Study
Started 24 44
Completed 22 44
Not Completed 2 0
Reason Not Completed
non-compliant             2             0
Arm/Group Title Targeted Dosing Historical Control Total
Hide Arm/Group Description 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. Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day. Total of all reporting groups
Overall Number of Baseline Participants 22 44 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Weeks
Number Analyzed 22 participants 44 participants 66 participants
1
(0 to 2)
1
(0 to 2)
1
(0 to 2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 44 participants 66 participants
Female
14
  63.6%
28
  63.6%
42
  63.6%
Male
8
  36.4%
16
  36.4%
24
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 44 participants 66 participants
22 44 66
1.Primary Outcome
Title Dose Adjustments
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Dosing Historical Control
Hide Arm/Group Description:
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.
Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
Overall Number of Participants Analyzed 22 44
Mean (Standard Error)
Unit of Measure: Number of dose adjustments
2.5  (0.334) 2.4  (0.211)
2.Secondary Outcome
Title Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls
Hide Description Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Athyreosis Patients With Dysgenetic Thyroids Patients With Eutopic Thyroids Historical Controls
Hide Arm/Group Description:

Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy at 15 mcg/kg for athyreosis.

Levothyroxine: Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.

Ultrasound

patients with dysgenetic thyroids
patients with eutopic thyroids
see title
Overall Number of Participants Analyzed 10 4 8 44
Mean (Standard Error)
Unit of Measure: dose adjustments
2.7  (0.275) 2  (0.275) 1  (0.275) 2  (0.275)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not monitored as all subjects were treated according to existing clinical standards of care
 
Arm/Group Title Targeted Dosing Historical Control
Hide Arm/Group Description 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. Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.
All-Cause Mortality
Targeted Dosing Historical Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Targeted Dosing Historical Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Targeted Dosing Historical Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Erica Eugster
Organization: Riley Hospital for Children
Phone: 317 944-3889
EMail: eeugster@iu.edu
Layout table for additonal information
Responsible Party: Erica Eugster, Indiana University
ClinicalTrials.gov Identifier: NCT02374593     History of Changes
Other Study ID Numbers: 1401199401
First Submitted: February 18, 2015
First Posted: March 2, 2015
Results First Submitted: June 6, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017