drugset / Trial / NCT04747275

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

NCT04747275

Phase 4 Terminated 6 enrolled Children's Mercy Hospital Kansas City
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2021-01-18
Primary completion
2021-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified
Subject Levothyroxine Other / unclassified Oral