TerminatedPhase 4

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

Stopped: Transitioned to multi site study with sponsor

United States6 participantsStarted 2021-01-18

Plain-language 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.

Who can participate

Age range2 Months – 4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tolerability as Assessed by the CareCAT Tool

Timeframe: 4 months

Trial details

NCT IDNCT04747275

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-01

Results submitted2022-10-17

View on ClinicalTrials.gov More Hypothyroidism trials