Status:
TERMINATED
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Hypothyroidism
Trisomy 21
Eligibility:
All Genders
2-4 years
Phase:
PHASE4
Brief Summary
Children with levothyroxine (T21) have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For an age group unable to swa...
Detailed Description
Hypothyroidism is a common medical disorder in children with Trisomy 21 (T21). Treatment with oral tablet levothyroxine (L-T4) is primarily used to treat this condition. However, children with T21 hav...
Eligibility Criteria
Inclusion
- Trisomy 21 children age 2 months to less than 5 years of age
- Prior confirmed diagnosis of congenital or acquired hypothyroidism
Exclusion
- Gestational age ≤ 35 weeks, concomitant anticonvulsant medications, history of nonadherence with medication or medical visit schedule
- Subjects must be able to take oral medication, no G-tube or parental fed subjects
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04747275
Start Date
January 18 2021
End Date
November 1 2021
Last Update
September 13 2023
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108