Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Hypothyroidism Clinical Trial

Official title:

Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04878614
• Other study ID #: IRB#20-002097
• Status: Terminated
• Phase: Phase 4
• Start date: May 5, 2021
• Est. completion date: February 16, 2022

Study information

• Verified date: April 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test a liquid levothyroxine formula and examine if it will lead to improvement in management of thyroid function and if it improves hypothyroid symptoms that patients experience.

Description:

Patients who require enteral nutrition through an enteral feeding tube and have hypothyroidism often struggle with the management of hypothyroidism. Hypothyroidism usually requires lifelong treatment except in some cases. It has been clinically observed the traditional management of hypothyroidism is to crush the tablet and administer the medical through the enteral nutrition tube and hold the feeds for one hour. However, management of the hormonal profile has been noted to have variable results with this method. Limited data is available about the effectiveness of levothyroxine liquid formulation in outpatients' dependent on enteral feeding tubes for administration.

Therefore, we propose a study to assess if daily treatment of, Tirosint-SOL (liquid levothyroxine, IBSA pharma Inc.), will improve thyroid function tests in individuals requiring enteral nutrition and are hypothyroid in a prospective, randomized study in a population requiring enteral nutrition. We hypothesize that Tirosint-SOL will lead to improvement in management in their thyroid function tests resulting in possible improvement in hypothyroid symptoms experienced by the patients.

This will be a randomized controlled trial. The study will be conducted in patients who have uncontrolled hypothyroidism on levothyroxine therapy. These patients will also be dependent on enteral nutrition and medication administration through the gastrostomy tube. The participants will be followed at UCLA Enteral Nutrition Clinic. Participants will be randomized 1:1 to either continue current management with the same dose or to dose equivalent liquid levothyroxine. At baseline (week 0) and week 6-8, TSH and thyroid function tests will be performed. In addition, medical history and physical, body weight, HR, blood pressure, nutritional intake by a registered dietitian will be done at each visit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age 18 years old or older

• G-tube/G-J tube dependent for medication administration

• Hypothyroid patients on levothyroxine tablet

• TSH>5 on levothyroxine

Exclusion Criteria:

• J-tube

• Unstable cardiac condition

• Unstable gastrointestinal condition

• Unable to reliably administer medication

• Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.

• In the opinion of the study investigator, any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• Levothyroxine Tablet
Standard clinical management
• Levothyroxine Sodium
Liquid levothyroxine through enteral feeding tube

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of TSH	evaluate change in thyroid hormonal panel	6 weeks
Secondary	percentage of patients with therapeutic FT4	evaluate change in thyroid hormonal panel	6 weeks
Secondary	percentage of patients with therapeutic FT3	evaluate change in thyroid hormonal panel	6 weeks