Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04747275
Study type Interventional
Source Children's Mercy Hospital Kansas City
Contact
Status Terminated
Phase Phase 4
Start date January 18, 2021
Completion date November 1, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05975866 - The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato N/A
Not yet recruiting NCT05334771 - Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
Withdrawn NCT01707056 - The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma N/A
Completed NCT00094237 - Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT03612908 - TSHβX1 and D2 THR92ALA in Pregnancy
Completed NCT04782856 - Energy Metabolism in Thyroidectomized Patients Phase 2
Completed NCT01921452 - Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit Phase 4
Completed NCT01197183 - Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France N/A
Recruiting NCT05247476 - Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients. Phase 4
Recruiting NCT03754621 - Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
Completed NCT02959827 - Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Completed NCT04124705 - A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Phase 2
Withdrawn NCT02577367 - Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding Phase 4
Completed NCT04098991 - Improving White Matter Integrity With Thyroid Hormone
Not yet recruiting NCT03257566 - Hypothyroidism in Patients With Type 1 Diabetes N/A
Terminated NCT02567877 - Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?
Completed NCT02280330 - Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months Phase 4
Completed NCT00403390 - Generic vs. Name-Brand Levothyroxine N/A
Not yet recruiting NCT06096454 - Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance Phase 4