Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City

Criteria

Inclusion Criteria:

• Trisomy 21 children age 2 months to less than 5 years of age

• Prior confirmed diagnosis of congenital or acquired hypothyroidism

Exclusion Criteria:

• 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