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Thyroid Hormone Replacement

Oral Tablet Levothyroxine (L-T4) first, then Liquid Stable Levothyroxine (L-T4) Tirosint-SOL for Hypothyroidism

Phase 4
Waitlist Available
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial tests if a liquid thyroid medication is easier for younger children to take than a pill, leading to better compliance and better health outcomes.

Eligible Conditions
  • Hypothyroidism
  • Down Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability as Assessed by the CareCAT Tool
Secondary outcome measures
Adherence to Taking Study Medication

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oral Tablet Levothyroxine (L-T4) first, then Liquid Stable Levothyroxine (L-T4) Tirosint-SOLExperimental Treatment2 Interventions
Participants continue conventional therapy of LT4 tablets for 8 weeks at current dose, after 8 weeks will crossover to receive Liquid Stable Levothyroxine (L-T4) Tirosint-SOL for 8 weeks. Participants total participation will be 16 weeks total.
Group II: Liquid Stable Levothyroxine (l-T4) TirosintSOL first, then Oral Tablet Levothyroxine (L-T4)Experimental Treatment2 Interventions
Participants start on Liquid Tirosint®-SOL for 8 weeks using continued same daily dose of LT4. Dose adjustments are allowed as needed, based on laboratory results and clinical response. Then Participants will crossover to conventional therapy of LT4 tablets for 8 weeks. Participants total participation will be 16 weeks total.

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,793 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Matthew Feldt 2021. "Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04747275.
~1 spots leftby Apr 2025
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