NCT04747275

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 2 Months – 4 Years
• Healthy volunteers: Not accepted

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 swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. For this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. We propose that Tirosint-SOL® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to L-T4 tablets.

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 have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. For this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. Until recently, there was no liquid preparation of L-T4 in the United States for use in children. Tirosint-SOL® (liquid stable L-T4) is now FDA-approved for use in children. The Investigator proposes that Tirosint-SOL® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to L-T4 tablets.

Conditions

• Hypothyroidism
• Trisomy 21

Interventions

Type	Name	Description
DRUG	Liquid stable levothyroxine (L-T4) Tirosint-SOL	Investigation of tolerability, palatability, and adherence of liquid levothyroxine (L-T4) for 8 weeks.
DRUG	Oral tablet levothyroxine (L-T4)	Investigation of tolerability, palatability, and adherence of maintained oral tablet levothyroxine (L-T4) for 8 weeks

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2021-02-10
• Last updated: 2023-09-13
• Results posted: 2023-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study