Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

Hypothyroidism Clinical Trial

Official title:

Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04747275
• Other study ID #: STUDY00001385
• Status: Terminated
• Phase: Phase 4
• Start date: January 18, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Hypothyroidism
• Trisomy 21

Intervention

Drug:
• Liquid stable levothyroxine (L-T4) Tirosint-SOL
Investigation of tolerability, palatability, and adherence of liquid levothyroxine (L-T4) for 8 weeks.
• Oral tablet levothyroxine (L-T4)
Investigation of tolerability, palatability, and adherence of maintained oral tablet levothyroxine (L-T4) for 8 weeks

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability as Assessed by the CareCAT Tool	Utilize medication tolerability questionnaire, Care Children's Acceptance Tool (CAT), to understand parental perceptions of liquid stable L-T4.	4 months
Secondary	Adherence to Taking Study Medication	Evaluate differences in compliance with liquid stable L-T4 compared to L-T4 tablet. Evaluated in percentage of days compliant.	4 months